Apparatus and methods for manipulating and securing tissue

ABSTRACT

Apparatus and methods for manipulating and securing tissue are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. The stabilizing members can be adapted to become angled relative to a longitudinal axis of the elongate tubular member. Moreover, one or all the articulation controls and functions can be integrated into a singular handle assembly connectable to the tissue manipulation assembly via a rigid or flexible tubular body.

CROSS-REFERENCES TO RELATED APPLICATIONS

This is a continuation-in-part of U.S. patent application Ser. No.10/840,950, filed May 7, 2004 and is related to the following U.S.patent application Ser. Nos.: 10/735,030 filed Dec. 12, 2003; 10/954,666filed Sep. 29, 2004; 10/956,009 filed Sep. 29, 2004; 10/955,243 filedSep. 30, 2004; and 10/955,244 filed Sep. 30, 2004, each of which isincorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to methods and apparatus for forming andsecuring gastrointestinal (“GI”) tissue folds. More particularly, thepresent invention relates to methods and apparatus for reducing theeffective cross-sectional area of a gastrointestinal lumen.

Morbid obesity is a serious medical condition pervasive in the UnitedStates and other countries. Its complications include hypertension,diabetes, coronary artery disease, stroke, congestive heart failure,multiple orthopedic problems and pulmonary insufficiency with markedlydecreased life expectancy.

A number of surgical techniques have been developed to treat morbidobesity, e.g., bypassing an absorptive surface of the small intestine,or reducing the stomach size. However, many conventional surgicalprocedures may present numerous life-threatening post-operativecomplications, and may cause atypical diarrhea, electrolytic imbalance,unpredictable weight loss and reflux of nutritious chyme proximal to thesite of the anastomosis.

Furthermore, the sutures or staples that are often used in thesesurgical procedures typically require extensive training by theclinician to achieve competent use, and may concentrate significantforce over a small surface area of the tissue, thereby potentiallycausing the suture or staple to tear through the tissue. Many of thesurgical procedures require regions of tissue within the body to beapproximated towards one another and reliably secured. Thegastrointestinal lumen includes four tissue layers, wherein the mucosalayer is the inner-most tissue layer followed by connective tissue, themuscularis layer and the serosa layer.

One problem with conventional gastrointestinal reduction systems is thatthe anchors (or staples) should engage at least the muscularis tissuelayer in order to provide a proper foundation. In other words, themucosa and connective tissue layers typically are not strong enough tosustain the tensile loads imposed by normal movement of the stomach wallduring ingestion and processing of food. In particular, these layerstend to stretch elastically rather than firmly hold the anchors (orstaples) in position, and accordingly, the more rigid muscularis and/orserosa layer should ideally be engaged. This problem of capturing themuscularis or serosa layers becomes particularly acute where it isdesired to place an anchor or other apparatus transesophageally ratherthan intra-operatively, since care must be taken in piercing the toughstomach wall not to inadvertently puncture adjacent tissue or organs.

One conventional method for securing anchors within a body lumen to thetissue is to utilize sewing devices to suture the stomach wall intofolds. This procedure typically involves advancing a sewing instrumentthrough the working channel of an endoscope and into the stomach andagainst the stomach wall tissue. The contacted tissue is then typicallydrawn into the sewing instrument where one or more sutures or tags areimplanted to hold the suctioned tissue in a folded condition known as aplication. Another method involves manually creating sutures forsecuring the plication.

One of the problems associated with these types of procedures is thetime and number of intubations needed to perform the various proceduresendoscopically. Another problem is the time required to complete aplication from the surrounding tissue with the body lumen. In the periodof time that a patient is anesthetized, procedures such as for thetreatment of morbid obesity or for GERD must be performed to completion.Accordingly, the placement and securement of the tissue plication shouldideally be relatively quick and performed with a minimal level ofconfidence.

Another problem with conventional methods involves ensuring that thestaple, knotted suture, or clip is secured tightly against the tissueand that the newly created plication will not relax under any slackwhich may be created by slipping staples, knots, or clips. Otherconventional tissue securement devices such as suture anchors, twistties, crimps, etc. are also often used to prevent sutures from slippingthrough tissue. However, many of these types of devices are typicallylarge and unsuitable for low-profile delivery through the body, e.g.,transesophageally.

Moreover, when grasping or clamping onto or upon the layers of tissuewith conventional anchors, sutures, staples, clips, etc., may of thesedevices are configured to be placed only after the tissue has beenplicated and not during the actual plication procedure.

BRIEF SUMMARY OF THE INVENTION

In creating tissue plications, a tissue plication tool having a distaltip may be advanced (transorally, transgastrically, etc.) into thestomach. The tissue may be engaged or grasped and the engaged tissue maybe moved to a proximal position relative to the tip of the device,thereby providing a substantially uniform plication of predeterminedsize. In order to first create the plication within a body lumen of apatient, various methods and devices may be implemented. The anchoringand securement devices may be delivered and positioned via an endoscopicapparatus that engages a tissue wall of the gastrointestinal lumen,creates one or more tissue folds, and disposes one or more of theanchors through the tissue fold(s). The tissue anchor(s) may be disposedthrough the muscularis and/or serosa layers of the gastrointestinallumen.

One variation of an apparatus which may be used to manipulate tissue andcreate a tissue fold may generally comprise an elongate tubular memberhaving a proximal end, a distal end, and a length therebetween, anengagement member which is slidably disposed through the tubular memberand having a distal end adapted to engage tissue, a first stabilizingmember and a second stabilizing member positioned at the tubular memberdistal end and adapted to stabilize tissue therebetween, wherein thefirst and second stabilizing members are further adapted to be angledrelative to a longitudinal axis of the elongate tubular member, and adelivery tube adapted to pivot about the first stabilizing member

The elongate tubular member or launch tube may be advanced from itsproximal end at a handle located outside a patient's body such that aportion of the launch tube is forced to rotate at a hinge or pivot andreconfigure itself such that the distal portion forms a curved orarcuate shape that positions the launch tube opening perpendicularlyrelative to a longitudinal axis of body. The launch tube, or at least aportion of the launch tube, is preferably fabricated from a highlyflexible material or it may be fabricated, e.g., from Nitinol tubingmaterial which is adapted to flex, e.g., via circumferential slots, topermit bending.

The tissue engagement member may be an elongate member, e.g., a wire,hypotube, etc., which has a tissue grasper or engager attached orintegrally formed at its distal end for grasping or engaging the tissue.In one variation, the tissue grasper may be formed as a helix having auniform outer diameter with a constant pitch. The helix 80 may beattached to an elongate acquisition member via any suitable fasteningmethod, e.g., adhesives, solder, etc. Alternatively, the helix may beintegrally formed from the distal portion of the acquisition member bywinding or coiling the distal portion in a helix configuration.

Alternative configurations for the helix may include a number ofvariations. For instance, the helix may have a varied pitch or one ormore regions with varying pitch along the length of the helix.Alternatively, a helix may include a piercing needle extending throughthe center and protruding distally of the helix. Other variations mayinclude a dual-helix, a helix having a decreasing diameter, the additionof an articulatable grasping jaw in combination with the helix.Moreover, the helix may be completely or partially hollow with one ormore deployable anchors positioned within or advanced through hollowhelix.

Alternative variations for the helix may also include optional measuresto prevent the helix from inadvertently damaging any surrounding tissue.For example, one variation may include a sheathed helix assembly whileanother variation may have an insertion member which defines anatraumatic distal end which may be advanced through the center of thehelix. Another alternative may include a helix which may be configuredto reconfigure itself into a straightened configuration to facilitateits removal from the tissue. In such a device, the helix may beelectrically connected via a connection of wires to a power source.

In addition to the variations of the tissue grasper or helix, thestabilizing members, otherwise called extension members, may alsoinclude various embodiments. For instance, the upper and/or lowerextension members or bails may also be configured with any of the helixvariations as practicable. Although the upper and lower extensionmembers or bails may be maintained rigidly relative to one another, theupper and/or lower extension members may be alternatively configured toarticulate from a closed to an open configuration or conversely from anopen to a closed configuration for facilitating manipulation orstabilization of tissue drawn between the bail members.

Articulation or manipulation of the extension members may beaccomplished via any number of methods. For instance, the upper and/orlower extension members may include a pivoting cam member, a linkageassembly, biased extension members which are urged closed or open, etc.Moreover, lower extension member may alternatively be extended in lengthrelative to upper extension member or one or both extension members maybe configured to have atraumatic blunted ends to prevent inadvertentlydamaging surrounding tissue.

Moreover, it is preferable to have sufficient clearance with respect tothe lower extension member so that unhindered deployment of the needleassembly or anchors from the apparatus is facilitated. One method forensuring unhindered deployment is via a lower extension member having asplit opening defined near or at its distal end. Alternatively, thelower extension member may be configured to create a “C”-shaped memberwhich allows for an opening along the member.

Alternatively, the lower extension member may be fabricated from anon-conductive material upon which wires may be integrated such that theentire lower member may be electrically conductive to selectively ablateregions of tissue, if so desired.

Aside from creating ablation regions, the tissue manipulation assemblymay be connected to the tubular body via a hinged or segmentedarticulatable portion which allows the tissue manipulation assembly tobe reconfigured from a low-profile configuration straightened relativeto the tubular body to an articulated configuration where the assemblyforms an angle relative to the tubular body. The articulatable portionmay be configured to allow the assembly to become articulated in asingle plane or it may also be configured to allow a full range ofmotion unconstrained to a single plane relative to tubular body tofacilitate manipulation of the tissue.

In addition to the extension members, the launch tube itself may befabricated from a metal such as Nitinol, stainless steel, titanium,etc., to facilitate the flexure of the tube. Such a tube may beselectively scored or cut to enhance the directional flexibility of thetube.

The launch tube may be advanced distally until the deployed needle bodyof the needle assembly emerges from the launch tube perpendicularly tothe tissue drawn between the extension members, and particularly toupper extension member. Thus, the distal opening of the launch tube maybe configured to form an angle, β, relative generally to the tissuemanipulation assembly. The angle, β, is preferably close to 90° but itmay range widely depending upon the amount of tissue grasped as well asthe angle desired.

A distal portion of the launch tube may also be modified to include anextended portion which is configured to remain straight even when thelaunch tube is flexed into its deployment configuration. This extendedportion may provide additional columnar support to a needle body passingthrough during needle deployment from the launch tube to help ensure thelinear deployment of the needle body into or through the tissue.

Alternatively, the needle body may define a cross-sectional shape, otherthan circular, which is keyed to the extended distal portion of thelaunch tube. The needle body may be keyed to the launch tube to ensure aspecified deployment trajectory of the needle body from the keyed launchtube. Alternatively, the launch tube may be overdriven relative to thetissue manipulation assembly and upper extension member.

The needle assembly which is advanced through the launch tube maygenerally comprise the needle body attached or integrally formed with atubular catheter or push tube. The needle body is preferably a hollowtapered needle which is configured to pierce into and through tissue.The needle body may have a variety of tapered piercing ends tofacilitate its entry into tissue. One variation which may be utilized toensure the needle trajectory through the tissue may include a curvableneedle body deployed from the launch tube. Such a needle body may beconstrained into a straightened configuration when positioned within thelaunch tube. However, once deployed the needle body may be adapted toreconfigure itself into a curved configuration directed towards thetissue manipulation assembly. The needle body may be curved via an anvilconfigured to receive and deflect the travel of the needle body into acurved needle body.

Alternatively, the needle body may be replaced with a fiber optic needlewhich may be deployed through the launch tube to provide visualizationof the tissue region prior to, during, or after anchor deployment. Inanother alternative, advancement of the needle body into and/or throughthe tissue may be facilitated via an ultrasonic vibrating needle body ora torqueable needle body which may be torqued about its proximal end tofacilitate entry into the tissue. The torqueable needle body may beconnected via a catheter length having high-torque characteristics.

Rather than deploying anchors from the needle assembly via a distalopening in the needle body, the tissue anchor may alternatively bedeployed through one or more side openings defined proximally of thedistal tip of the needle body. In yet another alternative, the needlebody may have gradations or indicators along its surface to provide avisual indication to the surgeon or physician of the position of theneedle body when advanced into or through the tissue or when deployedfrom the launch tube.

Moreover, the outer surface of the needle body may be dimpled to enhancethe visualization of the needle body within the patient body. Moreover,dimples may also enhance the visualization of needle body underultrasound imaging. Aside from dimples, the outer surface of the needlebody may be coated or covered with a radio-opaque material to furtherenhance visualization of the needle body.

The tissue manipulation assembly may be manipulated and articulatedthrough various mechanisms. One such assembly which integrates each ofthe functions into a singular unit may comprise a handle assembly whichis connected via a tubular body to the tissue manipulation assembly.Such a handle assembly may be configured to separate from the tubularbody, thus allowing for reusability of the handle. A tissue manipulationarticulation control may also be positioned on the handle to provide forselective articulation of the tissue manipulation assembly.

One particular variation of the handle assembly may have handleenclosure formed in a tapered configuration which is generallysymmetrically-shaped about a longitudinal axis extending from the distalend to the proximal end of the handle assembly. The symmetric featuremay allow for the handle to be easily manipulated by the user regardlessof the orientation of the handle enclosure during a tissue manipulationprocedure.

To articulate the multiple features desirably integrated into a singularhandle assembly, e.g., advancement and/or deployment of the launch tube,anchor assembly, needle assembly, articulation of the extension membersand tissue manipulation assembly, etc., a specially configured lockingmechanism may be located within the handle enclosure. Such a lockingmechanism may generally be comprised of an outer sleeve disposed aboutinner sleeve where the outer sleeve has a diameter which allows for itsunhindered rotational and longitudinal movement relative to the innersleeve. A needle deployment locking control may extend radially from theouter sleeve and protrude externally from the enclosure for manipulationby the user. The outer sleeve may also define a needle assembly travelpath along its length. The travel path may define the path through whichthe needle assembly may traverse in order to be deployed.

The needle assembly may define one or more guides protruding from thesurface of the assembly which may be configured to traverse within thetravel path. The inner sleeve may also define guides protruding from thesurface of the inner sleeve for traversal within grooves defined in thehandle enclosure. Moreover, the outer sleeve is preferably disposedrotatably about the inner sleeve such that the outer sleeve and innersleeve are configured to selectively interlock with one another in acorresponding manner when the locking control is manipulated intospecified positions.

The needle deployment assembly may be deployed through the approximationassembly by introducing the needle deployment assembly into the handleand through the tubular body such that the needle assembly is advancedfrom the launch tube and into or through approximated tissue. Anelongate and flexible sheath or catheter may extend removably from theneedle assembly control or housing which may be interconnected via aninterlock which may be adapted to allow for the securement as well asthe rapid release of the sheath from the housing through any number offastening methods, e.g., threaded connection, press-fit, releasable pin,etc. The needle body, which may be configured into any one of thevariations described above, may extend from the distal end of the sheathwhile maintaining communication between the lumen of the sheath andneedle opening.

An elongate pusher may comprise a flexible wire or hypotube which istranslationally disposed within the sheath and movably connected withinthe housing. A proximally-located actuation member may be rotatably orotherwise connected to the housing to selectively actuate thetranslational movement of elongate pusher relative to the sheath fordeploying the anchors from the needle opening. The anchor assembly maybe positioned distally of the elongate pusher within the sheath fordeployment from sheath. The housing for the needle deployment assemblymay also define an indicator window along its length to provide a visualindicator utilized to indicate the position of the elongate pusherwithin the sheath.

To ensure that the anchor is not prematurely ejected from the needleassembly, various interlocking features or spacing elements may beemployed. For instance, adjacent anchors positioned within the needledeployment assembly may be interlocked with one another via a temporaryinterlocking feature. Likewise, the elongate pusher and an adjacentanchor may be optionally interlocked together as well. Such aninterlocking feature may enable the anchor assembly to be advanceddistally as well as withdrawn proximally within the sheath and needlebody in a controlled manner without the risk of inadvertently pushingone or more anchors out of the needle body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a side view of one variation of a tissue plicationapparatus which may be used to create tissue plications and to delivercinching or locking anchors into the tissue.

FIGS. 1B and 1C show detail side and perspective views, respectively, ofthe tissue approximation assembly of the device of FIG. 1A.

FIG. 2A is a detail side view of the device shown in FIGS. 1A–1Cadvanced into a body lumen and positioned adjacent to a tissue wall.

FIG. 2B is a detail side view of the device shown in FIG. 2A with thetissue grasper engaging the tissue wall.

FIG. 2C is a detail side view of the device shown in FIGS. 2A and 2Bforming a tissue fold.

FIG. 2D is a detail side view of the device shown in FIGS. 2A–2C withthe needle assembly piercing the tissue fold.

FIG. 3A shows a cross-sectional side view of an anchor delivery assemblydelivering a basket-type anchor into or through a tissue fold.

FIG. 3B shows a cross-sectional side view of multiple tissue folds whichmay be approximated towards one another and basket anchors as beingdeliverable through one or both tissue folds.

FIG. 4A shows a side view of one variation for a tissue engaging helix.

FIG. 4B shows a side view of another variation for a helix having areduced pitch.

FIG. 4C shows a side view of another variation for a helix having avaried pitch.

FIG. 4D shows a side view of another variation for a helix having apiercing needle positioned through the helix.

FIG. 4E shows a side view of another variation having a dual helix.

FIG. 4F shows a side view of another variation for a helix having adecreasing diameter.

FIG. 4G shows a side view of another variation for a helix combined witha grasper.

FIGS. 5A and 5B show a hollow helix variation for deploying anchorsdirectly through the helix.

FIGS. 6A and 6B show another variation of a helix with a protectivesheath which may be advanced over the helix.

FIGS. 7A and 7B show another variation of a helix with an atraumaticmember which may be advanced longitudinally through the helix.

FIG. 8 shows another variation of a helix with a blunted member whichmay be advanced longitudinally through the helix.

FIGS. 9A and 9B show a helix which may be energized to reform into astraightened configuration, respectively, to facilitate its withdrawalfrom tissue.

FIG. 10 shows a helix variation which may be energized by a power sourcefor use in ablating surrounding tissue. FIG. 11A and 11B show side viewsof one variation of the tissue manipulation assembly having cam-actuatedextension members.

FIGS. 11C and 11D show detail views of the cam-actuation for theassembly of FIGS. 11A and 11B.

FIGS. 12A and 12B show side views of another variation of extensionmembers which are biased towards one another.

FIGS. 13A and 13B show side views of another variation of extensionmembers which are actuated via a linkage assembly.

FIGS. 14A to 14C show side views of another variation of extensionmembers which are actuatable via one or more hinged arms interconnectingthe extension members.

FIGS. 15A and 15B show side views of another variation where one or moreextension members are biased away from one another.

FIGS. 16A and 16B show side views of another variation where one or moreextension members are configured to be passively biased.

FIGS. 17A and 17B show side views of another variation of extensionmembers which are actuatable via a translatable sleeve.

FIG. 18 shows a side view of a tissue manipulation assembly with a lowerextension member having a longer length than the upper extension member.

FIG. 19 shows a side view of another variation where one or bothextension members may have tips atraumatic to tissue.

FIGS. 20A and 20B views of a variation of lower extension members whichmay be configured to be actuatable.

FIG. 20C show a top view of a lower extension member which may beconfigured into a “C” shape. FIGS. 21A and 21B show perspective and topviews of a lower extension member having one or more energize-able wiresdisposed thereon for tissue ablation.

FIGS. 23A to 23C show side views of a tissue manipulation assembly whichmay be configured to articulate into an angle relative to the tubularbody.

FIGS. 24A and 24B show side and perspective detail views, respectively,of a launch tube specially configured to flex in specified planes.

FIGS. 24C and 24D show side views of a portion of the launch tube havingone or more coatings or coverings.

FIG. 25 shows an illustrative side view of the angle formed between thedeployed needle assembly and a longitudinal axis of the tissuemanipulation assembly.

FIG. 26A shows a partial side view of a launch tube variation having anextended launch tube distal portion for aligning the needle body fordeployment.

FIGS. 26B and 26C show cross-sectional views of the needle body andlaunch tube distal portion having various keyed cross-sectional areas.

FIG. 27A shows another cross-sectional view where the needle body may bekeyed to the launch tube.

FIG. 27B shows a side view of the keyed needle body of FIG. 27A.

FIG. 28 shows a partial side view of an over-driven launch tube.

FIGS. 29A and 29B show partial side views of an assembly having curveddeployable needle assemblies.

FIG. 30 shows a variation where the needle body may be curved via ananvil.

FIG. 31 shows another variation in which an optical fiber or an opticalfiber configured as a needle body may be advanced through a launch tubeto provide visualization.

FIG. 32 shows a variation of the needle body which may be ultrasonicallyactuated.

FIG. 33 shows a torqueable variation of the needle body.

FIGS. 34A and 34B show needle body variations which may be configured todeploy tissue anchors via a side opening.

FIGS. 35A to 35C show end views of a tissue manipulation assembly whichmay incorporate various colors into the device to facilitateorientation.

FIGS. 36A to 36C show the corresponding top views, respectively, of thedevice of FIGS. 35A to 35C.

FIGS. 37A to 37D show side views of various needle bodies which may becolored, have visual markers thereon, dimpled, or have radio-opaquecoatings respectively.

FIGS. 38A to 38C show partial side views of variations of a handle forcontrolling and articulating the tissue manipulation assembly.

FIGS. 39A to 39C show top, side, and cross-sectional views,respectively, of another variation of a handle having a multi-positionlocking and needle assembly advancement system.

FIG. 39D shows an assembly view of the handle of FIG. 39A connected tothe tissue manipulation assembly via a rigid or flexible tubular body orshaft.

FIGS. 40A and 40B show perspective and cross-sectional views,respectively, of another variation of a handle having a reversibleconfiguration.

FIGS. 41A and 41B show partial cross-sectional side and detail views,respectively, of another variation of a handle having a pivotablearticulation control.

FIG. 42A shows a side view of the handle of FIG. 41A having themulti-position locking and needle assembly advancement system.

FIGS. 42B to 42D show end views of the handle of FIG. 42A and thevarious positions of the multi-position locking and needle assemblyadvancement system.

FIG. 43A shows a perspective view of one variation of the multi-positionlocking and needle assembly advancement system.

FIGS. 43B to 43E show illustrative side views of the system of FIG. 43Aconfigured in various locking and advancement positions.

FIG. 44 illustrates a side view of a needle deployment assembly whichmay be loaded or advanced into an approximation assembly.

FIG. 45A shows a side view of one variation of a needle deploymentassembly.

FIG. 45B shows an exploded assembly of FIG. 45A in which the tubularsheath is removed to reveal the anchor assembly and elongate pusherelement.

FIGS. 46A and 46B show partial cross-sectional side views of a shuttleelement advanced within the needle assembly housing.

FIGS. 47A and 47B illustrate one variation of deploying the anchorsusing the needle assembly.

FIG. 47C illustrates a partial cross-sectional view of one variation ofthe needle and anchor assemblies positioned within the launch tube.

FIG. 48 shows a side view of another variation in which a manipulatablegrasping needle assembly may be loaded into the approximation assembly.

FIGS. 49A and 49B show detail side views of a variation of themanipulatable grasping needle of FIG. 48.

FIGS. 50A and 50B show detail side views of another variation of themanipulatable grasping needle which may be utilized to deploy anchors.

FIGS. 51A and 51B show partial cross-sectional views of various methodsfor aligning a suture through the anchor assembly within the needleassembly.

FIG. 51C shows a partial cross-sectional view of an anchor assemblyvariation utilizing a spacer between adjacent anchors within the needleassembly.

FIGS. 52A and 52B show perspective detail views of unexpanded anchorshaving interlocking features on one or more of the collars fortemporarily interlocking the anchors and/or elongate pusher to oneanother.

FIG. 52C shows a detail perspective view of a curved interlockingfeature which may be integrated on the distal end of the elongatepusher.

FIGS. 53A and 53B show another variation of an interlocking featurewhich may be integrated into one or more anchors.

FIGS. 54A to 54C show a curved-tab locking feature variation which maybe utilized in deploying one or more anchors.

FIGS. 55A to 55C show an interlocking feature variation which may beutilized in deploying one or more anchors.

FIGS. 56A to 56C show a tabbed locking feature variation which may beutilized in deploying one or more anchors.

FIGS. 57A to 57C show a pin and groove locking feature variation whichmay be utilized in deploying one or more anchors.

FIGS. 58A to 58C show a rotational coil locking feature variation whichmay be utilized in deploying one or more anchors.

FIGS. 59A to 59C show an electrolytic joint locking feature variationwhich may be utilized in deploying one or more anchors.

FIGS. 60A to 60C show a ball-groove locking feature variation which maybe utilized in deploying one or more anchors.

FIGS. 61A to 61C show a balled-joint locking feature variation which maybe utilized in deploying one or more anchors.

FIGS. 62A to 62C show a magnetic locking feature variation which maybeutilized in deploying one or more anchors.

FIG. 63 shows a locking feature variation utilizing a cross-member.

FIGS. 64A to 64C show various additional feature for controlling thedeployment of anchors.

FIG. 65 shows a variation for deploying multiple anchors adjacentlyaligned within a single needle assembly.

FIGS. 66A to 66C show partial cross-sectional side, bottom, and endviews, respectively, of another variation for deploying multiple anchorsin a controlled manner via corresponding retaining tabs.

DETAILED DESCRIPTION OF THE INVENTION

In creating tissue plications, a tissue plication tool having a distaltip may be advanced (transorally, transgastrically, etc.) into thestomach. The tissue may be engaged or grasped and the engaged tissue maybe moved to a proximal position relative to the tip of the device,thereby providing a substantially uniform plication of predeterminedsize. Examples of creating and forming tissue plications may be seen infurther detail in U.S. patent application Ser. No. 10/735,030 filed Dec.12, 2003, which is incorporated herein by reference in its entirety.

In order to first create the plication within a body lumen of a patient,various methods and devices may be implemented. The anchoring andsecurement devices may be delivered and positioned via an endoscopicapparatus that engages a tissue wall of the gastrointestinal lumen,creates one or more tissue folds, and disposes one or more of theanchors through the tissue fold(s). The tissue anchor(s) may be disposedthrough the muscularis and/or serosa layers of the gastrointestinallumen.

Generally, in creating a plication through which a tissue anchor may bedisposed within or through, a distal tip of a tissue plication apparatusmay engage or grasp the tissue and move the engaged tissue to a proximalposition relative to the tip of the device, thereby providing asubstantially uniform plication of predetermined size.

Formation of a tissue fold may be accomplished using at least two tissuecontact areas that are separated by a linear or curvilinear distance,wherein the separation distance between the tissue contact pointsaffects the length and/or depth of the fold. In operation, a tissuegrabbing assembly engages or grasps the tissue wall in its normal state(i.e., non-folded and substantially flat), thus providing a first tissuecontact area. The first tissue contact area then is moved to a positionproximal of a second tissue contact area to form the tissue fold. Thetissue anchor assembly then may be extended across the tissue fold atthe second tissue contact area. Optionally, a third tissue contact pointmay be established such that, upon formation of the tissue fold, thesecond and third tissue contact areas are disposed on opposing sides ofthe tissue fold, thereby providing backside stabilization duringextension of the anchor assembly across the tissue fold from the secondtissue contact area.

The first tissue contact area may be utilized to engage and then stretchor rotate the tissue wall over the second tissue contact area to formthe tissue fold. The tissue fold may then be articulated to a positionwhere a portion of the tissue fold overlies the second tissue contactarea at an orientation that is substantially normal to the tissue fold.A tissue anchor may then be delivered across the tissue fold at or nearthe second tissue contact area. An apparatus in particular which isparticularly suited to deliver the anchoring and securement devicesdescribed herein may be seen in further detail in co-pending U.S. patentapplication Ser. No. 10/840,950 filed May 7, 2004, which is incorporatedherein by reference in its entirety.

An illustrative side view of a tissue plication assembly 10 which may beutilized with the tissue anchors described herein is shown in FIG. 1A.The plication assembly 10 generally comprises a catheter or tubular body12 which may be configured to be sufficiently flexible for advancementinto a body lumen, e.g., transorally, percutaneously, laparoscopically,etc. Tubular body 12 may be configured to be torqueable through variousmethods, e.g., utilizing a braided tubular construction, such that whenhandle 16 is manipulated and rotated by a practitioner from outside thebody, the torquing force is transmitted along body 12 such that thedistal end of body 12 is rotated in a corresponding manner.

Tissue manipulation assembly 14 is located at the distal end of tubularbody 12 and is generally used to contact and form the tissue plication,as mentioned above. FIG. 1B shows an illustrative detail side view andFIG. 1C shows a perspective view of tissue manipulation assembly 14which shows launch tube 18 extending from the distal end of body 12 andin-between the arms of upper extension member or bail 20. Launch tube 18may define launch tube opening 24 and may be pivotally connected near orat its distal end via hinge or pivot 22 to the distal end of upper bail20. Lower extension member or bail 26 may similarly extend from thedistal end of body 12 in a longitudinal direction substantially parallelto upper bail 20. Upper bail 20 and lower bail 26 need not be completelyparallel so long as an open space between upper bail 20 and lower bail26 is sufficiently large enough to accommodate the drawing of severallayers of tissue between the two members.

Upper bail 20 is shown in the figure as an open looped member and lowerbail 26 is shown as a solid member; however, this is intended to bemerely illustrative and either or both members may be configured aslooped or solid members. Tissue acquisition member 28 may be an elongatemember, e.g., a wire, hypotube, etc., which terminates at a tissuegrasper or engager 30, in this example a helically-shaped member,configured to be reversibly rotatable for advancement into the tissuefor the purpose of grasping or acquiring a region of tissue to be formedinto a plication. Tissue acquisition member 28 may extend distally fromhandle 16 through body 12 and distally between upper bail 20 and lowerbail 26. Acquisition member 28 may also be translatable and rotatablewithin body 12 such that tissue engager 30 is able to translatelongitudinally between upper bail 20 and lower bail 26. To support thelongitudinal and rotational movement of acquisition member 28, anoptional guide or linear bearing 32 may be connected to upper 20 orlower bail 26 to freely slide thereon. Guide 32 may also be slidablyconnected to acquisition member 28 such that the longitudinal motion ofacquisition member 28 is supported by guide 32.

An example of a tissue plication procedure is seen in FIGS. 2A to 2D fordelivering and placing a tissue anchor and is disclosed in furtherdetail in co-pending U.S. patent application Ser. No. 10/840,950 filedMay 7, 2004, which has been incorporated by reference above. Tissuemanipulation assembly 14, as seen in FIG. 2A, may be advanced into abody lumen such as the stomach and positioned adjacent to a region oftissue wall 40 to be plicated. During advancement, launch tube 18 may beconfigured in a delivery profile such that tube 18 is disposed within orbetween the arms of upper bail 20 to present a relatively small profile.

Once tissue manipulation assembly 14 has been desirably positionedrelative to tissue wall 40, tissue grasper or engager 30 may be advanceddistally such that tissue grasper or engager 30 comes into contact withtissue wall 40 at acquisition location or point 42. As tissue grasper orengager 30 is distally advanced relative to body 12, guide 32, ifutilized, may slide distally along with tissue grasper or engager 30 toaid in stabilizing the grasper. If a helically-shaped tissue grasper orengager 30 is utilized, as illustrated in FIG. 2B, it may be rotatedfrom its proximal end at handle 16 and advanced distally until thetissue at point 42 has been firmly engaged by tissue grasper or engager30. This may require advancement of tissue grasper or engager 30 throughthe mucosal layer and at least into or through the underlying muscularislayer and possibly into or through the serosa layer.

The grasped tissue may then be pulled proximally between upper 20 andlower bails 26 via tissue grasper or engager 30 such that the acquiredtissue is drawn into a tissue fold 44, as seen in FIG. 2C. As tissuegrasper or engager 30 is withdrawn proximally relative to body 12, guide32 may also slide proximally to aid in stabilizing the device especiallywhen drawing the tissue fold 44.

Once the tissue fold 44 has been formed, launch tube 18 may be advancedfrom its proximal end at handle 16 such that a portion 46 of launch tube18, which extends distally from body 12, is forced to rotate at hinge orpivot 22 and reconfigure itself such portion 46 forms a curved orarcuate shape that positions launch tube opening 24 perpendicularlyrelative to a longitudinal axis of body 12 and/or bail members 20, 26.Launch tube 18, or at least portion 46 of launch tube 18, is preferablyfabricated from a highly flexible material or it may be fabricated,e.g., from Nitinol tubing material which is adapted to flex, e.g., viacircumferential slots, to permit bending. Alternatively, assembly 14 maybe configured such that launch tube 18 is reconfigured simultaneouslywith the proximal withdrawal of tissue grasper or engager 30 andacquired tissue 44.

As discussed above, the tissue wall of a body lumen, such as thestomach, typically comprises an inner mucosal layer, connective tissue,the muscularis layer and the serosa layer. To obtain a durable purchase,e.g., in performing a stomach reduction procedure, the staples oranchors used to achieve reduction of the body lumen are preferablyengaged at least through or at the muscularis tissue layer, and morepreferably, the serosa layer. Advantageously, stretching of tissue fold44 between bail members 20, 26 permits an anchor to be ejected throughboth the muscularis and serosa layers, thus enabling durablegastrointestinal tissue approximation.

As shown in FIG. 2D, once launch tube opening 24 has been desirablypositioned relative to the tissue fold 44, needle assembly 48 may beadvanced through launch tube 18 via manipulation from its proximal endat handle 16 to pierce preferably through a dual serosa layer throughtissue fold 44. Needle assembly 48 is preferably a hollow tubular needlethrough which one or several tissue anchors may be delivered through andejected from in securing the tissue fold 44, as further described below.

Because needle assembly 48 penetrates the tissue wall twice, it exitswithin the body lumen, thus reducing the potential for injury tosurrounding organs. A detail cross-sectional view is shown in FIG. 3A ofanchor delivery assembly 50 in proximity to tissue fold F. In thisexample, tissue fold F may comprise a plication of tissue created usingthe apparatus described herein or any other tool configured to createsuch a tissue plication. Tissue fold F may be disposed within agastrointestinal lumen, such as the stomach, where tissue wall W maydefine the outer or serosal layer of the stomach. Anchor deliveryassembly may generally comprise launch tube 18 and needle assembly 48slidingly disposed within launch tube lumen 52. Needle assembly 48 isgenerally comprised of needle 54, which is preferably a hollow needlehaving a tapered or sharpened distal end to facilitate its travel intoand/or through the tissue. Other parts of the assembly, such as upperand lower bail members 20, 26, respectively, and tissue acquisitionmember 28 have been omitted from these figures only for clarity.

Once launch tube 18 has been desirably positioned with respect to tissuefold F, needle 54 may be urged or pushed into or through tissue fold Fvia delivery push tube or catheter 64 from its proximal end preferablylocated within handle 16. Delivery push tube or catheter 64 may comprisean elongate flexible tubular member to which needle 54 is connected orattached via joint 62. Alternatively, needle 54 and delivery push tube64 may be integrally formed from a singular tubular member. Needle 54may define needle lumen 56 through which basket anchor assembly 66,i.e., distal anchor 58 and/or proximal anchor 60 may be situated duringdeployment and positioning of the assembly. A single suture or flexibleelement 76 (or multiple suture elements) may connect proximal anchor 60and distal anchor 58 to one another. For instance, element 76 maycomprise various materials such as monofilament, multifilament, or anyother conventional suture material, elastic or elastomeric materials,e.g., rubber, etc.

Alternatively, metals which are biocompatible may also be utilized forsuture materials. For instance, sutures may be made from metals such asNitinol, stainless steels, Titanium, etc., provided that they are formedsuitably thin and flexible. Using metallic sutures with the anchoringmechanisms described herein may additionally provide several benefits.For example, use of metallic suture material may decrease anypossibilities of suture failure due to inadvertent cutting or shearingof the suture, it may provide a suture better able to withstand theacidic and basic environment of the gastrointestinal system, and it mayalso enhance imaging of the suture and anchor assembly if examined underconventional imaging systems such as X-rays, fluoroscopes, MRI, etc. Asused herein, suture 76 may encompass any of these materials or any othersuitable material which is also biocompatible.

Needle 54 may optionally define a needle slot along its length to allowsuture 76 to pass freely within and out of needle 54 when distal anchor58 is ejected from needle lumen 56. Alternatively, rather than utilizinga needle slot, needle 54 may define a solid structure with suture 76being passed into and through needle lumen 56 via the distal opening ofneedle 54.

The proximal end of suture 76 may pass slidingly through proximal anchor60 to terminate in a suture loop. The proximal end of suture 76 mayterminate proximally of the apparatus 10 within control handle 16,proximally of control handle 16, or at some point distally of controlhandle 16. In this variation, a suture loop may be provided to allow fora grasping or hooking tool to temporarily hold the suture loop forfacilitating the cinching of proximal 60 and distal 58 anchors towardsone another for retaining a configuration of tissue fold F, as describedin further detail in U.S. patent application Ser. No. 10/840,950, whichhas been incorporated by reference above.

After needle assembly 48 has been pushed distally out through launchtube opening 24 and penetrated into and/or through tissue fold F, asshown in FIG. 3A, anchor pushrod or member 78 may be actuated also viaits proximal end to eject distal anchor 58. Once distal anchor 58 hasbeen ejected distally of tissue fold F, needle 54 may be retracted backthrough tissue fold F by either retracting needle 54 back within launchtube lumen 18 or by withdrawing the entire anchor delivery assembly 50proximally relative to tissue fold F.

Once needle 54 has been retracted, proximal anchor 60 may then beejected from launch tube 18 on a proximal side of tissue fold F. Withboth anchors 58, 60 disposed externally of launch tube 18 and suture 76connecting the two, proximal anchor 60 may be urged into contact againsttissue fold F, as shown in FIG. 3B. As proximal anchor 60 is urgedagainst tissue fold F, proximal anchor 60 or a portion of suture 76 maybe configured to provide any number of directionally translatablelocking mechanisms which provide for movement of an anchor along suture76 in a first direction and preferably locks, inhibits, or prevents thereverse movement of the anchor back along suture 76. In otheralternatives, the anchors may simply be delivered through variouselongate hollow tubular members, e.g., a catheter, trocars, etc.

The basket anchors may comprise various configurations suitable forimplantation within a body lumen. Basket anchors are preferablyreconfigurable from a low profile delivery configuration to a radiallyexpanded deployment configuration in which a number of struts, arms, ormesh elements may radially extend once released from launch tube 18 orneedle 54. Materials having shape memory or superelastic characteristicsor which are biased to reconfigure when unconstrained are preferablyused, e.g., spring stainless steels, Ni—Ti alloys such as Nitinol, etc.In FIGS. 3A and 3B, each of the basket anchor 58, 60 is illustrated ashaving a number of reconfigurable struts or arm members 72 extendingbetween distal collar 68 and proximal collar 70; however, this isintended only to be illustrative and suitable basket anchors are notintended to be limited to baskets only having struts or arms. Examplesof suitable anchors are further described in detail in U.S. patentapplication Ser. No. 10/612,170, which has already been incorporatedherein above.

FIG. 3B shows distal basket anchor 58 delivered through tissue fold Fvia needle 54 and launch tube 18. As above, the other parts of theplication assembly, such as upper and lower bail members 20, 26,respectively, and tissue acquisition member 28 have been omitted fromthese figures only for clarity.

FIG. 3B shows one variation where a single fold F may be secured betweenproximal anchor 60 and distal anchor 58′. As seen, basket anchor 58′ hasbeen urged or ejected from needle 54 and is shown in its radiallyexpanded profile for placement against the tissue surface. In such acase, a terminal end of suture 76 may be anchored within the distalcollar of anchor 58′ and routed through tissue fold F and through, or atleast partially through, proximal anchor 60, where suture 76 may becinched or locked proximally of, within, or at proximal anchor 60 viaany number of cinching mechanisms. Proximal anchor 60 is also shown in aradially expanded profile contacting tissue fold F along tissue contactregion 74. Locking or cinching of suture 76 proximally of proximalanchor 60 enables the adequate securement of tissue fold F.

Various examples of cinching devices and methods which may be utilizedwith the tools and devices herein are described in further detail inU.S. patent application Ser. No. 10/840,950 filed May 7, 2004, which hasbeen incorporated herein above.

If additional tissue folds are plicated for securement, distal basketanchor 58 may be disposed distally of at least one additional tissuefold F′, as shown in FIG. 3B, while proximal anchor 60 may be disposedproximally of tissue fold F. As above, suture 76 may be similarlyaffixed within distal anchor 58 and routed through proximal anchor 60,where suture 76 may be cinched or locked via proximal anchor 60, asnecessary. If tissue folds F and F′ are to be positioned into appositionwith one another, distal basket anchor 58 and proximal anchor 60 may beapproximated towards one another. As described above, proximal anchor 60is preferably configured to allow suture 76 to pass freely therethroughduring the anchor approximation. However, proximal anchor 60 is alsopreferably configured to prevent or inhibit the reverse translation ofsuture 76 through proximal anchor 60 by enabling uni-directional travelof anchor 60 over suture 76. This cinching feature thereby allows forthe automated locking of anchors 58, 60 relative to one another duringanchor approximation.

With respect to the anchor assemblies described herein, the types ofanchors shown and described are intended to be illustrative and are notlimited to the variations shown. For instance, several of the tissueanchor variations are shown as “T”-type anchors while other variationsare shown as reconfigurable “basket”-type anchors, which may generallycomprise a number of configurable struts or legs extending between atleast two collars or support members. Other variations of these or othertypes of anchors are also contemplated for use in an anchor assembly.Moreover, a single type of anchor may be used exclusively in an anchorassembly; alternatively, a combination of different anchor types may beused in an anchor assembly. Furthermore, the different types of cinchingor locking mechanisms are not intended to be limited to any of theparticular variations shown and described but may be utilized in any ofthe combinations or varying types of anchors as practicable.

Tissue Engagement Tools

As mentioned above, tissue acquisition member 28 may be an elongatemember, e.g., a wire, hypotube, etc., which has a tissue grasper orengager 30 attached or integrally formed at its distal end for graspingor engaging the tissue. In one variation, the tissue grasper may beformed as a helix having a uniform outer diameter with a constant pitch,as shown in the detail view of helix 80 in FIG. 4A. Helix 80 may beattached to acquisition member 28 via any suitable fastening method,e.g., adhesives, solder, etc. Alternatively, helix 80 may be integrallyformed from the distal portion of acquisition member 28 by winding orcoiling the distal portion in a helix configuration.

In another variation, the tissue grasper may be formed into a helix 82having a pitch which is greater relatively than helix 80 such that thevariation of helix 82 has relatively fewer windings, as shown in FIG.4B. Alternatively, a multi-pitch helix 84 may be formed having one ormore regions with varying pitch along a length of helix 84. As seen inFIG. 4C, multi-pitch helix 84 may have a distal portion 86 having arelatively lower pitch and a proximal portion having a relatively higherpitch 88. A single helix having regions of varied pitch may be utilizedto initially pierce and grasp tissue onto the region of lower pitch 86;when the helix 84 is rotated to advance into or through the tissue, thepierced tissue advanced over helix 84 may be wound upon the region ofhigher pitch 88 where the tissue may be better adhered to helix 84 bythe tighter windings.

Another variation of a tissue grasper may be seen in FIG. 4D. In thisvariation, helix 90 may have a piercing needle 92 extending through thecenter and protruding distally of helix 90 to facilitate piercing of thetissue and initial entry of helix 90 into the tissue. Yet anothervariation is shown in FIG. 4E where a dual-helix variation may beutilized. Here, first helix 94 may be inter-wound with second helix 96in a dual helix configuration.

Another variation is shown in FIG. 4F in which helix 98 may define ahelix having a decreasing diameter distally of acquisition member 28. Inthis variation or any of the variations of the helix described herein,certain aspects of one helix variation may be utilized in any number ofcombinations with any of the other aspects of other variations aspracticable. For instance, the variation of the dual-helix in FIG. 4Emay also comprise the piercing needle 92 of FIG. 4D. This variation mayalso include aspects of the helix 84 having varying regions of differingpitch, as shown in FIG. 4C, and so on in any number of combinations aspracticable.

FIG. 4G shows yet another variation in dual grasping assembly 100 wherehelix 102 may utilize articulatable grasping jaw members 104, 106 incombination with the helix 102. As the helix 102 initially pierces androtatingly retains the tissue, acquisition member 28 may be withdrawnproximally to pull the tissue between jaws 104, 106, which may then bearticulated to further clamp onto the tissue to ensure tissue retentionby assembly 100. Articulatable jaws 104, 106 may optionally defineserrations or teeth 108, 110 upon one or more of the jaw members 104,106 in contact against the tissue to further facilitate tissueretention.

In addition to the various configurations, the tissue grasper may befurther utilized to retain tissue via tissue anchors. FIGS. 5A and 5Bshow side views of a helix variation 120 which may be completely orpartially hollow for engaging tissue. One or more deployable anchors 124may be positioned within or advanced through hollow helix 120. With atleast the distal portion or tip of hollow helix 120 pierced into orthrough the tissue T, as shown in FIG. 5A, tissue anchor 124 may beurged from opening 122 defined in hollow helix 120 through any number ofmethods, e.g., an elongate pusher. Once tissue anchor 124 has beendeployed or ejected from distal opening 122, helix 120 may be withdrawnproximally partially or entirely from tissue T while leaving anchor 124behind. Anchor 124 may be connected to suture 126 which may be routedthrough or connected to helix 120 such that creation of a tissue foldfrom tissue T may be achieved by pulling anchor 124 proximally, as shownin FIG. 5B. After the tissue T has been desirably manipulated or folded,suture 126 may be released from helix 120 so that helix 120 may bewithdrawn from the region.

During manipulation of the tissue and articulation of the helix withinthe patient's body, e.g., within the stomach, optional measures may betaken to prevent the helix from inadvertently damaging any surroundingtissue. One variation may be seen in the detail side view of sheathedhelix assembly 130 in FIG. 6A. The sheath 132 may completely orpartially cover helix 80 to present an atraumatic surface to thesurrounding tissue when the helix 80 is not in use within the patient'sbody, as shown in FIG. 6B. Additionally, sheath 132 may also be utilizedoutside the patient to protect helix 80 when handled for transport orduring preparation of the device for use. Sheath 132 may be optionallyadvanced distally over helix 80 or helix 80 may be withdrawn proximallyinto sheath 132.

Another variation for providing an atraumatic surface for the helix tosurrounding tissue may be seen in FIGS. 7A and 7B. As shown, helixassembly 140 may have an insertion member 142 which defines anatraumatic distal end 144 advanced through the center of helix 80. Whenthe helix 80 is not in use, insertion member 142 may be advanceddistally within helix 80 to the distal end of helix 80 such thatinadvertent tissue piercing is prevented by member 142.

Yet another variation is shown in FIG. 8 in which blunted element 150may be advanced through the center of helix 80 via an elongate deliverymember 152. When helix 80 is utilized, member 150 may be withdrawnproximally relative to helix 80 in the same manner as helix assembly 140above.

Another variation of the helix assembly is shown in the illustrativeside views of FIGS. 9A and 9B. In this variation, reconfigurable helix160 may be configured to have a configuration for facilitating itsadvancement into tissue or for withdrawing the helix 160 from tissue.FIG. 9A shows reconfigurable helix 160 is seen in its coiledconfiguration for piercing and adhering tissue thereto. Helix 160 may befabricated from a shape memory alloy, such as Nitinol, to have a relaxedconfiguration of a helix, as shown in FIG. 9A. Once energy is applied,helix 160 may be configured to reconfigure itself into a straightenedconfiguration 160′, as shown in FIG. 9B, to facilitate its removal fromthe tissue. Helix 160 may be electrically connected via electricallyconductive acquisition member 162 and connection or wires 164 to a powersource 166. If helix 160 were advanced into tissue in its coiledconfiguration, withdrawal of the helix 160 may be quickly effected byapplying energy to helix 160 via power source 166. Alternatively, powermay be applied to helix 160 such that its straightened configuration160′ takes shape to facilitate piercing into tissue. Power may then beremoved such that helix 160 conforms into its coiled configuration oncein the tissue such that the tissue adheres to the helix 160.

In the reconfigurable helix 160 above, the length of helix 160 may beinsulated to shield the surrounding tissue from the applied energy.However, another variation of the tissue grasping member may be seen inenergizable helix 170 in FIG. 10. In this variation, the entire lengthor a partial length of helix 170 may be uninsulated such that when helix170 is energized through electrical connection 174 and throughelectrically conductive acquisition member 172 via power source 176, theuninsulated portion or portions of energized helix 170 may be utilizedto contact and ablate selected regions of tissue. For instance, prior toor after a tissue fold has been formed, helix 170 may be energized toablate the areas of the tissue which are to be approximated towards oneanother to facilitate tissue adhesion between selected regions of tissuefolds.

As mentioned above, in this variation or any of the variations of thehelix, certain aspects of one helix variation may be utilized in anynumber of combinations with any of the other aspects of other variationsas practicable.

Extension Members

In addition to the variations of the tissue grasper or helix, the upperand/or lower extension members or bails may also be configured into avariety of embodiments which may be utilized in any number ofcombinations with any of the helix variations as practicable. Althoughthe upper and lower extension members or bails may be maintained rigidlyrelative to one another, the upper and/or lower extension members may bealternatively configured to articulate from a closed to an openconfiguration or conversely from an open to a closed configuration forfacilitating manipulation or stabilization of tissue drawn between thebail members.

In operation, once the selected region of tissue has been acquired bythe tissue grasper 30, the obtained tissue may be proximally withdrawnbetween the bail members, which may act as stabilizers for the tissue.To accommodate large portions of grasped tissue between the bailmembers, one or both bail members may be articulated or urged to openapart from one another to allow the tissue to enter and becomepositioned between the bail members. One or both bail members may thenbe articulated or urged to clamp or squeeze the tissue fold between thebail members to facilitate stabilization of the tissue fold for tissuemanipulation and/or anchor deployment and/or any other procedure to beundertaken.

One such articulatable extension assembly may be seen in the side viewsof FIGS. 11A and 11B. Other features such as the launch tube and tubularbody have been omitted merely for the sake of clarity for the followingillustrations. As seen in FIG. 11A, upper extension member 182 and lowerextension member 184 of active extension assembly 180 may be configuredto have an open or spread configuration relative to one another whenguide or linear bearing 186 is positioned distally along upper extensionmember 182. Linear bearing 186 may be configured to slide freely alongupper extension member 182 when urged by acquisition member 28 distallyor proximally. Rather than having linear bearing 186 slide along upperextension member 182, it may be configured alternatively to slide alonglower extension member 184.

With tissue grasper 30 and acquisition member 28 distally protrudingfrom extension members 182, 184, as shown in FIG. 11A, the desiredregion of tissue may be acquired by rotating tissue grasper 30 into thetissue. Once tissue has been acquired by tissue grasper 30, the tissuemay be pulled between the opened extension members 182, 184 byproximally withdrawing tissue grasper 30 and linear bearing 186 may beforced proximally over upper extension member 182, as shown in thedetail view of FIG. 11C. One or more projections or pistons 188 mayprotrude proximally from linear bearing 186 such that one or more ofthese projections 188 comes into contact with actuation lever or member192, as shown in FIG. 11D, which may be located proximally of extensionmembers 182, 184 and connected in a pivoting relationship with lowerextension member 184 about pivot 190. As linear bearing 186 is urgedproximally and projection 188 presses against actuation lever 192, lowerextension member 184 may be rotated about pivot 190 such that lowerextension member 184 is urged towards upper extension member 182 tosecurely clamp onto and retain any tissue positioned between theextension members 182, 184.

Another articulatable extension assembly may be seen in assembly 200 inthe side views of FIGS. 12A and 12B. In this variation, upper extensionmember 202 may project distally opposite lower extension member 204which may be biased to close towards upper extension member 202. Whentissue grasper 30 is advanced to engage tissue, as shown in FIG. 12A,linear bearing 206 may be urged distally along upper extension member202 via acquisition member 28 such that lower extension member 204 isforced or wedged away from upper extension member 202. Once the tissueis engaged and withdrawn proximally, linear bearing 206 may be pulledproximally while sliding along lower member 204 and allowing lowermember 204 to spring back towards upper member 202 and over any tissuepositioned therebetween, as shown in FIG. 12B.

Another articulatable extension assembly is shown in the side views ofextension assembly 210 of FIGS. 13A and 13B. In this variation, upperextension member 212 and/or lower extension member 214 may be connectedto linkage assembly 218 located proximally of the extension members 212,214. Linkage assembly 218 may be manipulated via any number of controlmechanisms such as control wires to urge extension members 212, 214between open and closed configurations. Alternatively, linkage assembly218 may be configured to open or close upon the proximal or distaladvancement of linear bearing 216 relative to linkage assembly.

FIGS. 14A to 14C show side views of another variation in extensionassembly 220 where upper and lower extension members 222, 224 arearticulatable between open and closed configurations via a pivoting armor member 234 interconnecting the two. In this example, a first end ofpivoting arm 234 may be in a pivoting connection at pivot 228 withlinear bearing 226, which may slide translationally along upper member222. A second end of pivoting arm 234 may also be in a pivotingconnection with lower extension member 224 at pivot 230, which mayremain fixed to lower member 224. Acquisition member 28 may also be in athird pivoting connection with pivoting arm 234 at pivot 232, which mayalso be configured to allow for the linear translation of acquisitionmember therethrough.

In operation, when acquisition member 28 and tissue grasper 30 isadvanced distally, as shown in FIG. 14A, both upper and lower extensionmembers 222, 224 are in a closed configuration with linear bearing 226being advanced distally along upper extension member 222. As tissuegrasper 30 is withdrawn proximally between extension members 222, 224,pivoting arm 234 may be pivoted about fixed pivot 230 on lower member224 while upper member 222 is urged into an open configuration as linearbearing 226 is urged proximally over upper member 222, as shown in FIG.14B. This expanded or open configuration allows for the positioning oflarge portions of tissue to be drawn between the extension members 222,224 for stabilization. FIG. 14C shows tissue grasper 30 as having beenfurther withdrawn and linear bearing 226 urged proximally such thatupper member 222 is urged back into a closed configuration relative tolower member 224. The closing of extension members 222, 224 allows forthe members to further clamp upon any tissue therebetween for furtherstabilization of the tissue.

FIGS. 15A and 15B show another alternative in active extension assembly240. In this variation, upper extension member 242 may be biased toextend away from lower extension member 244. As shown in FIG. 15A, upperextension member 242 may remain in an open configuration relative tolower member 244 for receiving tissue therebetween. In this variation,biased upper member 242 may be urged into a closed configuration bypivoting the launch tube 18 about pivot 246, which may be located alongupper member 242. As launch tube 18 is pivoted into an anchor deploymentconfiguration, the pivoting action may urge upper member 242 towardslower member 244 to clamp upon any tissue therebetween.

FIGS. 16A and 16B show yet another alternative in assembly 250 whereupper extension member 252 and/or lower extension member 254 may bepassively urged into an open configuration. In this example, lowerextension member 254 is shown as being flexed from a relaxedconfiguration in FIG. 16A to a flexed configuration in FIG. 16B. Aslinear bearing 256 is withdrawn proximally, any tissue engaged to tissuegrasper 30 may urge lower extension member 254 from its normal position258 to its flexed and opened position. Accordingly, lower extensionmember 254 and/or upper extension member 252 may be made from arelatively flexible plastic or metallic material, e.g., Nitinol, springstainless steel, etc. When tissue is removed from between the extensionmembers 252, 254, lower extension member 254 may return to its normalconfiguration 258.

FIGS. 17A and 17B show side views of another assembly 260 in which upperand/or lower extension members 262, 264 may be biased or configured toflex away from one another, as shown in FIG. 17A. Once linear bearing266 and tissue grasper 30 has been retracted, an outer sleeve 268slidingly disposed over tubular body 12 may be pushed distally such thatsleeve 268 is slid over at least a proximal portion of extension members262, 264 such that they are urged towards one another into a closedconfiguration onto tissue which may be present therebetween, as shown inFIG. 17B.

Aside from features such as articulation of the extension members, theextension members themselves may be modified. For instance, FIG. 18shows a side view of extension assembly 270 where lower extension member274 may be extended in length relative to upper extension member 272.The length of lower extension member 274 may be varied depending uponthe desired result. Alternatively, upper extension member 272 may beshortened relative to lower extension member 274. The lengthening oflower extension member 274 may be utilized to present a more stableplatform for tissue approximated between the extension members 262, 264.

Another alternative for modifying the extension members is seen in theside view of FIG. 19 in extension assembly 280. In this example, one orboth extension members 282, 284 may be configured to have atraumaticblunted ends 286 which may be further configured to be flexible to allowtissue to slide over the ends. Moreover, atraumatic ends 286 may beconfigured in a variety of ways provided that an atraumatic surface orfeature is presented to the tissue.

In addition to atraumatic features, the lower extension member of thetissue manipulation assembly may be varied as well. For example, as theneedle assembly and tissue anchors are deployed from the launch tube,typically from the upper extension member, it is preferable to havesufficient clearance with respect to the lower extension member so thatunhindered deployment is facilitated. One method for ensuring unhindereddeployment is via a lower extension member having a split openingdefined near or at its distal end, as shown in the perspective view oftissue manipulation assembly 290 in FIG. 20A. Such a split may allow forany deployed anchors or suture an opening through which to be releasedfrom assembly 290.

Additionally, the jaws which define the opening may be articulatable aswell relative to lower extension member 294. As shown in the bottom viewof FIG. 20B, articulatable lower extension assembly 292 may have one orboth jaw members 296, 298 articulatable via pivots 300, 302,respectively, relative to lower extension member 294 such that one orboth jaw members 296, 298 are able to be moved between a closedconfiguration, as shown in FIG. 20A, and an open configuration, as shownin FIG. 20B. This variation in assembly 290 may allow for any needle oranchor assemblies to easily clear lower extension member 294.

Another variation of lower extension member 304 is shown in the bottomview of FIG. 20C. In this variation, an enclosing jaw member 306 mayextend from lower extension member 304 such that an opening 308 alongeither side of extension member 304 is created. Such an opening 308 maycreate a “C”-shaped lower extension member 304 which may facilitateneedle and anchor deployment from the tissue manipulation assembly.

Another variation of a tissue manipulation assembly 310 may be seen inthe illustrative partial perspective view of FIG. 21A. In addition toarticulation or release features, one or both extension members may beutilized to selectively ablate regions of tissue. Assembly 310 forinstance may have a tissue ablation assembly 312 integrated into thelower extension member 320. Such a tissue ablation assembly 312, as seenin the top view of FIG. 21B, may incorporate one or more wires orelectrically conductive elements 318 upon lower extension member 320 tocreate a tissue ablation region. The lower extension member 320 may befabricated from a non-conductive material upon which wires 318 may beintegrated. Alternatively, the entire lower member 320 may beelectrically conductive with regions selectively insulated leavingnon-insulated areas to create ablation regions 318. The wires or regions318 may be electrically connected via wires 314 to power source 316,which may provide various forms of energy for tissue ablation, e.g.,radio-frequency, microwave, etc.

One example for use of the ablative tissue manipulation assembly may beseen in FIGS. 22A to 22E where tissue approximation assembly 330 may beseen with tissue manipulation assembly 14 advanced through an optionalshape-lockable overtube 332. Ablation region 318 is integrated into thelower extension member 320 of the tissue manipulation assembly, asabove. Alternatively, region 318 may, for example, comprise an abrasivesurface disposed on lower extension member 320. Alternatively, the lowerextension member 320 may comprise an ablation electrode for injuringmucosal tissue.

As seen in FIG. 22B, when tissue wall 40 is folded between the extensionmembers of assembly 14, target mucosal tissue 334 contacts lowerextension member 320 as well as ablation region 318. Passive or activeactuation of ablation region 318 may then injure and/or remove thetarget mucosal tissue 334. As further seen in FIG. 22C, this proceduremay be repeated at one or more additional tissue folds 336, 338 that maythen be approximated together, as in FIG. 22D. The contacting injuredregions of mucosal tissue promote healing and fusion 340 of theapproximated folds, as in FIG. 22E.

Aside from variations on aspects of the tissue manipulation assembly,the entire assembly may also be modified to adjust the tissuemanipulation assembly position relative to the tubular body upon whichthe assembly is attachable. FIG. 23A shows a distal portion of tubularbody 12 and tissue manipulation assembly 14 connected thereto. Whiletubular body 12 may comprise a rigid or flexible length, tissuemanipulation assembly 14 may be further configured to articulaterelative to tubular body 12, as shown in FIG. 23B, to further enhancethe maneuverability and manipulation capabilities of tissue manipulationassembly 14. In one example, assembly 14 may be connected to tubularbody 12 via a hinged or segmented articulatable portion 350, shown inthe detail FIG. 23C, which allows assembly 14 to be reconfigured from alow-profile configuration straightened relative to tubular body 12 to anarticulated configuration where assembly 14 forms an angle, a, relativeto tubular body 12. The angle, α, may range anywhere from 180° to −180°depending upon the desired level of articulation. Articulatable portion350 may be configured to allow assembly 14 to become articulated in asingle plane or it may also be configured to allow a full range ofmotion unconstrained to a single plane relative to tubular body 12.Articulation of assembly 14 may be accomplished any number of variousmethods, e.g., control wires.

Any of the variations of the tissue manipulation assemblies or aspectsof various features of the tissue manipulation assemblies is intended tobe utilized in any number of combinations with other aspects of othervariations as practicable. Moreover, any of the variations relating tothe tissue manipulation assemblies may also be used in any number ofcombinations, as practicable, with the helix variations described above,if so desired.

Launch Tube

An illustrative side view of a partial launch tube 18 configured foranchor deployment may be seen in FIG. 24A. Launch tube 18 is typicallyconfigured to partially translate relative to the tissue manipulationassembly such that a distal portion of the launch tube 18 may bearticulated perpendicularly to the tissue to be pierced. Launch tube 18may be made from a variety of flexible materials which are flexible yetsufficiently strong to withstand repeated flexing of the tube.

FIG. 24B shows a portion 360 of launch tube 18 which may be fabricatedfrom a metal such as Nitinol, stainless steel, titanium, etc. Tofacilitate the flexure of tube 18, such a tube may be selectively scoredor cut to enhance the directional flexibility of the tube 18.Accordingly, in one variation, a plurality of circumferential cuts orslits 366 may be made in the portion of launch tube 18 which is flexed.Cuts 366 may extend between one or more lengths or spines 362, 364 ofuncut tube material which may extend over the length of the flexibleportion. These spines 362, 364 in combination with the cuts 366 mayfacilitate the directional flexibility or bending of launch tube 18 in asingular bending plane. Cuts 366 may be made along the launch tube 18using any number methods, e.g., mechanical cutting, laser cutting,chemical etching, etc.

Another variation of launch tube 18 is shown in the partial views ofFIGS. 24C and 24D. Launch tube wall 368 may be seen in FIG. 24C with anoptional inner covering or coating 370 while FIG. 24D shows anothervariation of launch tube wall 368 with an optional additional outercoating 372. Inner covering or coating 370 may be comprised of alubricious material, e.g., PTFE, etc., to facilitate the ease with whichthe needle assembly may be advanced or withdrawn through launch tube 18.Moreover, outer covering or coating 372 may also comprise a lubriciousmaterial to facilitate the translation of launch tube relative totubular body 12. Either or both coatings 370, 372 may also ensure thestructural integrity of launch tube 18 as well.

In advancing launch tube 18 into a configuration where its distalopening is transverse to the tissue to be pierced, launch tube 18 ispreferably advanced until the deployed needle body 380 of the needleassembly emerges from launch tube 18 perpendicularly to the tissue drawnbetween the extension members, and particularly to upper extensionmember 20. Thus, the distal opening of launch tube 18 may be configuredto form an angle, β, relative generally to the tissue manipulationassembly, as shown in FIG. 25. Angle, β, is preferably close to 90° butit may range widely depending upon the amount of tissue grasped as wellas the angle desired; thus, the launch tube 18 may be configured totranslate over a specified distance via detents or locks to ensure theformed angle.

Aside from ensuring the deployment angle, β, of launch tube 18, a distalportion of launch tube 18 may be modified to include an extended portion382 which is configured to remain straight even when launch tube 18 isflexed into its deployment configuration, as shown in FIG. 26A. Extendedportion 382 may comprises an uncut portion of launch tube 18 or it mayalternatively comprise a strengthened region of the launch tube 18. Ineither case, the extended portion 382 may provide additional columnarsupport to needle body 380 during needle deployment from launch tube 18to help ensure the linear deployment of the needle body 380 into orthrough the tissue.

Another variation for needle deployment from launch tube 18 may be seenin the cross-sectional views of FIGS. 26B and 26C, which show the needlebody 380 positioned within the distal portion 382 of launch tube 18. Toensure deployment of needle body 380 in a perpendicular or desiredtrajectory, needle body 380 may define a cross-sectional shape, otherthan circular, which is keyed to the extended distal portion 382 oflaunch tube 18. Thus, needle body 380 may define an ellipticalcross-sectional shape within a complementary elliptically-shaped distalportion 384, as seen in FIG. 26B. Alternatively, needle body 380 may beconfigured into a polygonal shape, e.g., octagonal, within anoctagonally-shaped distal portion 386, as seen in FIG. 26C. Any numberof other cross-sectional shapes may be employed, e.g., rectangles,hexagons, heptagons, octagons, etc.

Rather than utilizing various cross-sectional shapes, needle body 390may instead be keyed to launch tube 394 to ensure a specified deploymenttrajectory of needle body 390 from keyed launch tube 394, as shown inthe cross-sectional view of FIG. 27A. One variation for keying mayinclude attaching or forming a key or projection 392, e.g., a length ofwire, along one or more sides of needle body 390, as shown in the sideview of needle body 390 and delivery catheter 398. Launch tube 394 maydefine a groove or channel 396 along an inner surface through which thekey 392 on needle body 390 may travel within while maintaining anorientation of needle body 390 relative to launch tube 394.

Yet another variation for ensuring needle trajectory from the launchtube may be seen in the partial cross-sectional view of FIG. 28. Variousfeatures of the tissue manipulation assembly have been omitted merelyfor clarity. As shown, launch tube 400 may be overdriven relative to thetissue manipulation assembly and upper extension member 20, i.e., theangle, θ, formed between the deployed needle body 402 and upperextension member 20 is greater than 90°. The launch tube 400 anddeployed needle body 402 may be overdriven to ensure that the trajectoryof needle body 402 is directed towards the assembly rather than awayfrom the assembly.

Any of the launch tube variations described herein is not intended to belimited to the examples described but is intended to be utilized in anynumber of combinations with other aspects of other variations aspracticable. Moreover, any of the variations relating to the launch tubevariations may also be used in any number of combinations, aspracticable, with variations of other features as described above, if sodesired.

Needle Body

Generally, the launch tube needle is preferably a hollow tapered needlebody which is configured to pierce into and through tissue. The needlebody may have a variety of tapered piercing ends to facilitate its entryinto tissue. One variation which may be utilized to ensure the needletrajectory through the tissue may be seen in FIG. 29A, which showscurved or curvable needle body 410 deployed from launch tube 18.

In this variation, needle body 410 may be constrained into astraightened configuration when positioned within launch tube 18.However, once deployed from launch tube 18, needle body 410 may beadapted to reconfigure itself into a curved configuration directedtowards the tissue manipulation assembly. Thus, curved needle body 410may be made from a super elastic alloy or shape memory alloy such asNitinol. FIG. 29B shows another variation in which curved needle body410 may be launched from an under-deployed launch tube 412.

Another variation for curving the needle body is illustrated in the sideview of FIG. 30. In this variation, needle body 420 may be curved via ananvil 422 configured to receive and deflect the travel of needle body420 into a curved needle body. Needle body 420 may be comprised of asuper elastic alloy such as Nitinol. Anvil 422 may be mounted on eitherlower extension member 26, as shown in the figure, or upper extensionmember 20, depending upon the desired results.

Yet another variation of the needle body may be seen in the illustrativeside view of FIG. 31 where the needle body may be replaced with a fiberoptic needle 430. Such a needle 430 may be deployed through the launchtube 18 to provide visualization of the tissue region prior to, during,or after anchor deployment. Alternatively, fiber optic needle 430 may beadvanced directly into or through the tissue region for visualization ofthe tissue. As shown, fiber optic needle 430 may be in communication viafiber optic wire or wires 432 to a processor 434 and an optional monitor436 for viewing the tissue region from outside the patient's body.

In another alternative, advancement of the needle body into and/orthrough the tissue may be facilitated via an ultrasonic vibrating needlebody 440, as shown in FIG. 32. Vibrating needle body 440 may beelectrically connected via wires 442 to power source 444 for driving theneedle body, e.g., using a piezoelectric transducer to supply thevibratory motion.

FIG. 33 illustrates yet another alternative where rather than utilizinga vibrating needle body, a torqueable needle body 450, which may betorqued about its proximal end, may be utilized to facilitate entry intothe tissue. The torqueable needle body 450 may be connected via acatheter length having high-torque characteristics, e.g., via braidingalong the catheter shaft. Moreover, needle body 450 may further definethreading 452 over its outer surface to facilitate entry of the needlebody 450 into the tissue. To remove the needle body 450 from the tissue,the direction of torque may simply be reversed while pulling proximallyon needle body 450.

Rather than deploying anchors from the needle assembly via a distalopening in the needle body, the tissue anchor may alternatively bedeployed through one or more side openings defined proximally of thedistal tip of the needle body. As seen in the detail view of alternativeneedle body 460 in FIG. 34A, tissue anchor 60 may be deployed fromneedle body 460 through side opening 462. A ramp or taper 464 may bedefined within needle body 460 leading to side opening 462 to facilitatethe ejection of the tissue anchors from needle body 460. FIG. 34B showsanother alternative needle body 466 having a side opening 462. Thisvariation, however, includes a tapered needle body with needle knife 468projecting distally from needle body 466. Needle knife 468 may beutilized to facilitate the initial entry into the tissue while taperedneedle body 466 may be used to dilate the opening created by needleknife 468 and facilitate the entry of needle body 466 into and/orthrough the tissue.

Another variation on the needle body and launch tube is shown in FIGS.35A to 36C. FIG. 35A shows an end view looking directly along tubularbody 12 towards the tissue manipulation assembly with the launch tube470 flexed into its deployment configuration. FIGS. 35B and 35C show theend view of FIG. 35A where the assembly is angled relatively to the leftand to the right, respectively. The terms “left” and “right” areintended to refer only to the orientation of the assembly as shown inthe figures and are used for illustrative purposes. FIG. 36A shows a topview of the assembly corresponding to FIG. 35A while FIGS. 36B and 36Calso show top views corresponding to FIGS. 35B and 35C, respectively.When the tissue assembly is visualized within the patient's body via alaparoscope or endoscope, determining the orientation of the assemblywith respect to the tissue may at times be difficult typically due tothe lack of depth perception. Thus, to aid with orientation of theassembly when oriented at some angle, co, as shown in FIGS. 35B, 35C,36B and 36C, portions of the assembly, such as launch tube 470 or theneedle assembly, may be coated or covered with a color, e.g., red,orange, yellow, green, blue, indigo, violet, silver, black, orcombinations thereof. The aid of coloring portions of the assembly mayhelp with gaining orientation of the device.

Aside from coloring the tissue manipulation assembly, portions of theneedle assembly may also be colored as well. FIG. 37A shows a needlebody 480 which may be colored with any of the colors described above tofacilitate orientation of the needle body 480 when deployed from thelaunch tube. In another alternative, needle body 482 may have gradationsor indicators 484 along its surface, as shown in FIG. 37B, to provide avisual indication to the surgeon or physician of the position of needlebody 482 when advanced into or through the tissue or when deployed fromthe launch tube. Each of the gradations 484 may be separated by auniform distance or various positions along the needle body 482 may bemarked to indicate specified locations.

FIG. 37C shows yet another variation in which the outer surface ofneedle body 486 may be dimpled 488. The presence of dimples 488 may beused to enhance the visualization of needle body 486 within the patientbody. Moreover, dimples 488 may also enhance the visualization of needlebody 486 under ultrasound imaging, if utilized, either for imaging theposition of needle body 486 or for locating needle body 486 within thepatient's body if the needle body 486 were to inadvertently break off.

Yet another variation is shown in the cross-sectional view of needlebody 490 in FIG. 37D. The outer surface of needle body 490 may be coatedor covered with a radio-opaque material 492 to further enhancevisualization of the needle body 490, for example, if x-ray orfluoroscopic imaging were utilized. The radio-opaque coating 492, e.g.,platinum, nickel, etc., may also be further coated with a lubriciousmaterial to facilitate needle insertion into and/or through the tissue.

Any of the needle body and needle assembly variations described hereinis not intended to be limited to the examples described but is intendedto be utilized in any number of combinations with other aspects of othervariations as practicable. Moreover, any of the variations relating tothe needle body variations may also be used in any number ofcombinations, as practicable, with variations of other features asdescribed above, if so desired.

Handle Assembly

The tissue manipulation assembly may be manipulated and articulatedthrough various mechanisms. One such assembly which integrates each ofthe functions into a singular unit may be seen in the handle assemblywhich is connected via tubular body 12 to the tissue manipulationassembly. Such a handle assembly may be configured to separate fromtubular body 12, thus allowing for reusability of the handle. Moreover,such a handle may be fabricated from a variety of materials such asmetals or plastics, provided that the materials are preferablybiocompatible. Examples of suitable materials may include stainlesssteel, PTFE, Delrin®, etc.

One variation of a handle assembly is shown in the illustrative sideview of handle 500 in FIG. 38A with half of handle enclosure 502 removedfor clarity for discussion purposes. As shown, handle enclosure 502 mayconnect with tubular body 12 at its distal end at tubular interface 504.The proximal end of handle 500 may define acquisition member opening 506which opens to acquisition member receiving channel 508 defined throughenclosure 502 from opening 506 to tubular interface 504. The acquisitionmember 28 may be routed through receiving channel 508 with the proximalend 510 of acquisition member 28 extending proximally of enclosure 502for manipulation by the user. Acquisition member proximal end 510 mayfurther have an acquisition member rotational control 512 that the usermay grasp to manipulate acquisition member 28.

Acquisition member receiving channel 508 preferably has a diameter whichis sufficiently large enough to allow for the translational androtational movement of acquisition member through the receiving channel508 during tissue manipulation. Acquisition member lock 524, e.g., ascrew or protrusion, may also extend at least partially into acquisitionmember receiving channel 508 such that lock 524 may be urged selectivelyagainst acquisition member 28 to freeze a position of acquisition member28, if so desired. The terminal end of receiving channel 508 may extendto tubular interface 504 such that receiving channel 508 and tubularbody 12 are in communication to provide for the passage of acquisitionmember 28 therethrough.

In addition to the acquisition member controls, the handle enclosure 502may also provide a needle assembly receiving channel 514 through whichneedle assembly control 516 and needle assembly catheter 518 may betranslated through. Needle assembly receiving channel 514 may extendfrom needle assembly opening 520 also to tubular interface 504. Needleassembly receiving channel 514 extends to tubular interface 504 suchthat needle assembly receiving channel 514 and tubular body 12 are alsoin communication to provide for the passage of needle assembly catheter518 therethrough.

In operation, once the tissue to be plicated has been acquired and drawnbetween the lower and upper extension members by acquisition member 28,as described above, the launch tube 18 may be advanced distally androtated into its deployment configuration. Once positioned fordeployment, the needle assembly may be advanced into and/or through thetissue by urging needle assembly control 516 and needle assemblycatheter 518 distally into needle assembly receiving channel 514, asshown by the advancement of control 516 in FIG. 38B. The tissue anchorsmay then be deployed from the needle assembly catheter 518 via theneedle assembly control 516, as further described below. Withdrawal ofthe needle assembly from the tissue may be accomplished by the proximalwithdrawal of needle assembly control 516 and assembly catheter 518.

Tissue manipulation articulation control 522 may also be positioned onhandle 500 to provide for selective articulation of the tissuemanipulation assembly, as shown above in FIGS. 23A to 23C. Thisvariation shows articulation control 522 rotatably positioned on handleenclosure 502 such that articulation control 522 may be rotated relativeto handle 500 to selectively control the movement of the tissuemanipulation assembly. Articulation control 522 may be operablyconnected via one or several control wires attached between articulationcontrol 522 and the tissue manipulation assembly. The control wires maybe routed through tubular interface 504 and extend through tubular body12.

FIG. 38C shows another variation of handle enclosure 502 where thetissue manipulation articulation control 526 may be positioned on a sidesurface of handle enclosure 502. Articulation control 526 may include aratcheting mechanism 528 within enclosure 502 to provide for controlledarticulation of the tissue manipulation assembly.

FIGS. 39A to 39C show top, side, and cross-sectional views,respectively, of another variation on the handle assembly. As seen inFIGS. 39A and 39B, an advancement control 530 may be adapted toselectively slide translationally and rotationally through a definedadvancement channel or groove 532 defined within handle enclosure 502.Advancement control 530 may be used to control the deployment andadvancement of needle assembly control 516 as well as deployment of thelaunch tube, as described in further detail below.

FIG. 39D shows an assembly side view of the handle assembly, tubularbody 12, and tissue manipulation assembly and the corresponding motionof the assembly when manipulated by the handle. As described above,tissue acquisition member proximal end 510 and acquisition membercontrol 512 may be advanced or withdrawn from the handle enclosure 502in the direction of arrow 534 to transmit the correspondingtranslational motion through tubular body 12 to tissue acquisitionmember 28 and tissue grasper 30, as indicated by the direction ofcorresponding arrow 536. Likewise, when acquisition member control 512is rotated relative to handle enclosure 502, as indicated by rotationalarrow 538, the corresponding rotational motion is transmitted throughtubular body 12 to tissue grasper 30 for screwing into or unscrewingfrom tissue, as indicated by corresponding rotational arrow 540. Asmentioned above, tubular body 12 may be rigid or flexible depending uponthe application utilized for the device.

Likewise, longitudinal translation of needle assembly control 516relative to enclosure 502, as indicated by the arrow may transmit thecorresponding longitudinal motion to the needle assembly through thelaunch tube when reconfigured for deployment. The tissue manipulationassembly articulation control 522 may also be seen in this handlevariation as being rotatable in the direction of arrow 542 relative tohandle enclosure 502. Depending upon the direction of articulation,control 522 may be manipulated to elicit a corresponding motion from thetissue manipulation assembly about hinge or articulatable section 350 inthe direction of arrows 544.

Another handle variation may be seen in the perspective view of handleassembly 550, as shown in FIG. 40A. This particular variation may havehandle enclosure 552 formed in a tapered configuration which allows forthe assembly 550 to be generally symmetrically-shaped about alongitudinal axis extending from its distal end 554 to its proximal end556. The symmetric feature of handle assembly 550 may allow for thehandle to be easily manipulated by the user regardless of theorientation of the handle enclosure 552 during a tissue manipulationprocedure. An additional feature which may further facilitate theergonomic usability of handle assembly 550 may further include at leastone opening 558 defined through the enclosure 552 to allow the user tomore easily grip and control the handle 550. Another feature may includegrips 560, 562 which may extend from either side of enclosure 552.

As seen in the figure, acquisition member 564 may include additionalfeatures to facilitate control of the tissue. For instance, in thisvariation, in addition to the rotational control 566, an additionalrotational control 568 may extend proximally from control 566 and have adiameter smaller than that of control 566 for controlling finerotational motion of acquisition member 564.

FIG. 40B shows a side view of the handle assembly 550 of FIG. 40A withthe enclosure 552 partially removed for clarity. As shown, needleassembly control 570 may be seen inserted within an additional needledeployment mechanism 576, as described below in further detail, withinneedle assembly receiving channel 574. Acquisition member 564 may alsobe seen positioned within acquisition member receiving channel 572.

Yet another variation of the handle assembly may be seen in the sideview of the handle assembly of FIG. 41A where the handle enclosure 522is partially removed for clarity. In this variation, needle deploymentmechanism lock 580, e.g., a screw or protrusion, may be configured tooperably extend at least partially into needle assembly receivingchannel 574 to selectively lock the launch tube and/or needle assemblycontrol within receiving channel 574. Also shown is acquisition memberreceiving channel 582 through which the acquisition member may betranslated and/or rotated. Acquisition member lock 584 may also be seento extend at least partially into the acquisition member receivingchannel 582 to selectively lock the acquisition member position, if sodesired. The acquisition member receiving channel 582 may be optionallythreaded 586 such that the acquisition member may be advanced orwithdrawn using a screw-like mechanism.

An additional needle deployment mechanism lock 594 may also be seenpivotally mounted about pivot 596 within enclosure 522. Mechanism 594may be biased via deployment mechanism biasing element 598, e.g., aspring, to maintain a biasing force against mechanism 594 such that theneedle assembly control may automatically become locked duringadvancement within enclosure 522 to allow for a more controlled anchordeployment and needle assembly advancement.

Moreover, one or more pivotable tissue manipulation assembly controls588 may be mounted to enclosure 522 and extend from one or both sides ofenclosure 522 to provide for articulation control of the tissuemanipulation assembly, as described above. As presently shown in FIG.41B in the detail side view from the handle assembly of FIG. 41A, one ormore control wires 592 may be connected to control 588 at control wireattachment points 600. Control 588 may pivot about tissue acquisitionpivot 590 located within handle enclosure 522. As control 588 ispivoted, the articulation of control wires 592 may articulate a positionof the tissue manipulation assembly, as discussed above. FIG. 41B showsan example of the range of motion which may be possible for control 588as it is rotated about pivot 590.

FIG. 42A shows a side view of another variation of handle enclosure 610which incorporates a needle deployment locking and advancement control612 which is adapted to be advanced and rotated within needle deploymenttravel 614 into various positions corresponding to various actions.Locking control 612 may be utilized in this variation to selectivelycontrol access of the needle assembly within handle enclosure 610 aswell as deployment of the needle assembly and launch tube advancementwith a single mechanism. A needle assembly, such as needle assembly 570,may be advanced into handle enclosure 610 with locking control 612initially moved into needle assembly receiving position 616, shown alsoin the end view of FIG. 42B. Once the needle assembly has been initiallyintroduced into enclosure 610, the needle assembly may be locked withinenclosure 610 by rotating locking control 612 into its needle assemblylocking position 618, clockwise rotation as shown in the end view ofFIG. 42C. The needle assembly may be locked within enclosure 610 toprevent the accidental withdrawal of the needle assembly from theenclosure 610 or inadvertent advancement of the needle assembly into thetissue.

With locking control 612 in the needle assembly locking position 618,the needle deployment mechanism within enclosure 610 may also belongitudinally translated in a distal direction by urging lockingcontrol 612 distally within needle deployment travel 614. Urging lockingcontrol 612 distally translates not only the needle deployment mechanismwithin enclosure 610, but may also translate the launch tube distallysuch that the launch tube distal portion is pivoted into its deploymentconfiguration, as described above. As the needle deployment mechanism isdistally translated within enclosure 610, the needle assembly may alsobe urged distally with the deployment mechanism such that needleassembly becomes positioned within the launch tube for advancing theneedle body into the tissue.

Once locking control 612 has been advanced distally, locking control 612may again be rotated into the needle assembly release position 620,clockwise rotation as shown in the end view of FIG. 42D. Once in therelease position 620, the needle assembly may be free to be translateddistally within enclosure 610 for advancing the needle assembly andneedle body relative to the launch tube and enclosure 610. To remove theneedle assembly from enclosure 610, the steps may be reversed by movinglocking control 612 proximally back to its initial needle assemblyreceiving position 616 so that the needle assembly is unlocked fromwithin enclosure 610. A new needle assembly may then be introduced intoenclosure 610 and the process repeated as many times as desired.

Details of one variation of the locking mechanism disposed within thehandle enclosure 610 are shown in the perspective view of FIG. 43A. Theother elements of the handle assembly have been omitted from thisillustration for clarity. The locking mechanism may generally becomprised of outer sleeve 630 disposed about inner sleeve 632. Outersleeve 630 preferably has a diameter which allows for its unhinderedrotational and longitudinal movement relative to inner sleeve 632.Needle deployment locking control 612 may extend radially from outersleeve 630 and protrude externally from enclosure 610, as describedabove, for manipulation by the user. Outer sleeve 630 may also defineneedle assembly travel path 636 along its length. Travel path 636 maydefine the path through which needle assembly 570 may traverse in orderto be deployed. Needle assembly 570 may define one or more guides 638protruding from the surface of assembly 570 which may be configured totraverse within travel path 636. Inner sleeve 634 may also define guides634 protruding from the surface of inner sleeve 634 for traversal withingrooves defined in handle enclosure 610. Moreover, outer sleeve 630 ispreferably disposed rotatably about inner sleeve 632 such that outersleeve 630 and inner sleeve 632 are configured to selectively interlockwith one another in a corresponding manner when locking control 612 ismanipulated into specified positions.

Turning to FIGS. 43B to 43E, the operation of the locking mechanism ofFIG. 43A is described in further detail. As needle assembly 570 isinitially introduced into handle enclosure 610 and the lockingmechanism, needle assembly 570 may be rotated until guides 638 are ableto slide into longitudinal receiving channel 640 of travel path 636defined in outer sleeve 630, as shown in FIGS. 43B and 43C. Lockingcontrol 612 may be partially rotated, as described above in FIGS. 42Band 42C, such that outer sleeve is rotated with respect to needleassembly 570 and guides 638 slide through transverse loading channel642, as shown in FIG. 43D. In this position, the locking mechanism maybe advanced distally to deploy the launch tube and to also advanceneedle assembly 570 distally in preparation for needle assembly 570deployment. Once the launch tube has been desirably advanced, lockingcontrol 612 may again be partially rotated, as shown in FIG. 42D, suchthat guides 638 on needle assembly 570 are free to then be advancedwithin longitudinal needle assembly channel 644 relative to the handleenclosure 610 for deploying the needle assembly 570 from the launch tubeand into or through the tissue. As mentioned above, the needle assembly570 may be removed from enclosure 610 and the locking mechanism byreversing the above procedure.

As above, any of the handle assembly variations described herein is notintended to be limited to the examples described but is intended to beutilized in any number of combinations with other aspects of othervariations as practicable. Moreover, any of the variations relating tothe handle assembly variations may also be used in any number ofcombinations, as practicable, with variations of other features asdescribed above, if so desired.

Needle Deployment Assembly

As described above, needle deployment assembly 650 may be deployedthrough approximation assembly 10 by introducing needle deploymentassembly 650 into the handle 16 and through tubular body 12, as shown inthe assembly view of FIG. 44, such that the needle assembly 656 isadvanced from the launch tube and into or through approximated tissue.Once the needle assembly 656 has been advanced through the tissue, theanchor assembly 658 may be deployed or ejected. Anchor assembly 658 isnormally positioned within the distal portion of tubular sheath 654which extends from needle assembly control or housing 652. Once theanchor assembly 658 has been fully deployed from sheath 654, the spentneedle deployment assembly 650 may be removed from approximationassembly 10, as described above, and another needle deployment assemblymay be introduced without having to remove assembly 10 from the patient.The length of sheath 654 is such that it may be passed entirely throughthe length of tubular body 12 to enable the deployment of needleassembly 656 into and/or through the tissue.

FIG. 45A shows a detailed assembly view of the needle deploymentassembly 650 from FIG. 44. In this variation, elongate and flexiblesheath or catheter 654 may extend removably from needle assembly controlor housing 652. Sheath or catheter 654 and housing 652 may beinterconnected via interlock 660 which may be adapted to allow for thesecurement as well as the rapid release of sheath 654 from housing 652through any number of fastening methods, e.g., threaded connection,press-fit, releasable pin, etc. Needle body 662, which may be configuredinto any one of the variations described above, may extend from thedistal end of sheath 654 while maintaining communication between thelumen of sheath 654 and needle opening 664.

Elongate pusher 666 may comprise a flexible wire or hypotube which istranslationally disposed within sheath 654 and movably connected withinhousing 652. A proximally-located actuation member 668 may be rotatablyor otherwise connected to housing 652 to selectively actuate thetranslational movement of elongate pusher 666 relative to sheath 654 fordeploying the anchors from needle opening 664. Anchor assembly 658 maybe seen positioned distally of elongate pusher 666 within sheath 654 fordeployment from sheath 654. Needle assembly guides 670 may also be seenprotruding from housing 652 for guidance through the locking mechanismdescribed above. FIG. 45B shows an exploded assembly view of the needledeployment assembly 650 from FIG. 45A. As seen, sheath 654 may bedisconnected from housing 652 via interlock 660 to reveal the elongatepusher 666 connected to housing 652 and the distal and proximal anchors58, 60, respectively, of anchor assembly 658.

FIGS. 46A and 46B show partial cross-sectional views of one variation ofhousing 652. As shown in FIG. 46A, elongate pusher 666 may be attachedto shuttle 682, which in turn may be connected to threaded interfaceelement 686. As actuation member 668 is manipulated, e.g., by rotatingit clockwise, lead screw 684 may be rotated about its longitudinal axisto advance threaded interface element 686 over lead screw 684 distallythrough shuttle channel 680, as shown in FIG. 46B, where shuttle 682 hasbeen advanced entirely through shuttle channel 680. Tubular sheathinterlock 688 may be seen at the distal portion of housing 652 throughwhich the elongate pusher 666 may be advanced. To reverse the directionof elongate pusher 666 and shuttle 682, actuation member 668 may bereversed in the opposite direction.

Another variation of the needle deployment assembly may be seen in FIGS.47A and 47B which show assembly side views. In this variation, housing652 may define an indicator window 690 along the length of housing 652to enable viewing of a visual indicator 692 which may be utilized toindicate the position of the elongate pusher 666 within the sheath 654.In the illustration of FIG. 47A, as actuation member 668 is manipulatedto advance pusher 666 distally, indicator 692 may move correspondinglywithin window 690. Positional indicators may also be marked along window690 to indicate to the user when specified limits have been reached. Forinstance, positional indicator 694 may be marked such that alignment ofindicator 692 with positional indicator 694 is indicative to the userthat distal anchor 58 has been deployed from sheath 654.

Likewise, an additional positional indicator 696 may be marked such thatalignment of indicator 692 with positional indicator 694 is indicativeto the user that the proximal anchor 60 has also been deployed fromsheath 654, as shown in FIG. 47B. Any number of positional indicators ormethods for visually marking may be utilized as the above examples aremerely intended to be illustrative and not limiting. Moreover, tofurther facilitate the visualization of anchor positioning within sheath654, the sheath itself may be fabricated from a transparent material,such as plastics, so that the user may visually locate a position of oneor both anchors during anchor deployment into or through the tissue.

FIG. 47C shows an illustrative cross-sectional view of the launch tube18 in its deployment configuration. Tubular sheath 654 and needle body662 may be seen positioned within the distal portion of launch tube 18ready for deployment into any tissue (not shown for clarity) which maybe positioned between upper and lower extension members 20, 26. Alsoshown are distal and proximal anchors 58, 60, respectively (suture isnot shown for clarity), positioned within sheath 654 distally ofelongate pusher 666.

FIG. 48 shows an assembly view of yet another variation in whichmanipulatable needle assembly 700 may be utilized with approximationassembly 10. Similar to the assembly above, manipulatable needleassembly 700 may be deployed through approximation assembly 10 byintroducing needle assembly 700 into the handle 16 and through tubularbody 12. Once the needle assembly has been advanced through the tissue,an anchor assembly may be deployed or ejected and/or the tissue orsuture may be manipulated via the assembly 700. A further detaileddescription of manipulatable needle assembly 700 is disclosed inco-pending U.S. patent application Ser. No. 10/898,684 filed Jul. 23,2004 and entitled “Manipulatable Grasping Needle”, which is incorporatedherein by reference in its entirety.

As shown in FIG. 48, an elongate flexible member 702 may be tubular suchthat at least one lumen is defined through the length of flexible member702. Handle 704 may be positioned at a proximal end of flexible member702 and control handle 706 may be likewise positioned. Control handle706 may be configured to enable the articulation of piercing andgrasping assembly 708 into an open or closed configuration, as describedin further detail below. Control handle 708, as well as handle 704,which is positioned at a distal end of flexible member 702, may beoperably connected to piercing and grasping assembly 708, e.g., viacontrol wires, which may run through the length of flexible member 702.

Flexible member 702 may be made from a variety of flexible materialssuch as polymers. If made from a polymeric material, flexible member 702may be reinforced along its length as necessary using various methodssuch as interspersing metallic braids, weaves, reinforcing wires, etc.,throughout the length of the flexible member 702. Alternatively,metallic materials, e.g., stainless steel, platinum, etc., andparticularly superelastic metals and alloys, e.g., Nitinol, etc., may beutilized in constructing flexible member 702 provided that the materialis sufficiently adapted to flex when manipulated. In the case ofstainless steel or like metals, the length of flexible member 702 may bescored or perforated to allow for additional flexibility. Moreover, thediameter of flexible member 702 may be varied to suit the application inwhich assembly 700 may be employed. For example, if assembly 700 wereadvanced, e.g., through a conventional endoscope for use in a patient'sstomach, flexible member may range anywhere in diameter from 2-3 mm andmay have a length greater than or less than 100 cm. These dimensions aremerely intended to be illustrative and are not intended to limit thesize or scope of the assembly 700.

As generally shown, piercing and grasping assembly 708 may be comprisedof needle body 710, which has a tapered or sharpened tip 712 forpiercing into or through tissue. Needle body 710 may also define anopening or lumen 714 therethrough for retaining and passing a tissueanchor, as described further below. As seen in the detail side view ofFIG. 49A, piercing and grasping assembly 708 may be configured into alow-profile closed configuration for advancement into the body and forpiercing into or through tissue. As piercing and grasping assembly 708is advanced into or through tissue, a length of suture 720 may bereleasably retained by assembly 708 between needle body 710 and graspingarm 716, which may be positioned proximally of tip 712 and/or needlebody 710.

Once piercing and grasping assembly 708 has been desirably advanced intoor through tissue, assembly 708 may be actuated into an openconfiguration where grasping arm 716 may project from needle body 710,as shown in FIG. 49B. In the open configuration, grasping arm 716 may beopen relative to needle body 710 such that suture 720 may be releasedfrom piercing and grasping assembly 708. Alternatively, piercing andgrasping assembly 708 may be manipulated to grasp a free length ofsuture. Linkage assembly 718, which may be actuated via a push and/orpull wire (not shown) contained within tubular member 702, may be usedto open and close needle body 710 and grasping arm 716. As shown, bothneedle body 710 and grasping arm 716 may each be actuated into an openedconfiguration relative to tubular member 702; alternatively, linkageassembly 718 may be utilized to actuate a single member, i.e., needlebody 710 or grasping arm 716, into an opened configuration for suturemanipulation or release.

Elongate tubular member 702 may be flexible or it may also beconstructed as a rigid shaft. In either case, one or several portions ofelongate member 702 may comprise an articulatable section 30 along alength of elongate member 702. A section of member 702 just proximal ofpiercing and grasping assembly 708 may be configured to be articulatablesuch that assembly 708 may be articulated via handle 704. One or severalcontrol wires may be routed through elongate member 702 in any number ofways to enable articulatable section 30 to conform to a desired shape.An elongate member 702 having one or several articulatable sections 30may enable assembly 708 to be manipulated about or around tissue suchthat suture manipulation is facilitated.

The piercing and grasping assembly 708 may be utilized in a variety ofdifferent procedures. In one instance, assembly 708 may be advanced intoa hollow body organ, e.g., a stomach, and used to pierce through createdtissue plications and deposit soft tissue anchors for securing thetissue plications. Examples of methods and devices for creating tissueplications may be seen in further detail in U.S. patent application Ser.No. 10/735,030 which has been incorporated by reference above. As shownin FIG. 50A, an expandable tissue anchor 722 may be seen positionedwithin opening 714 of needle body 710 for delivery. Suture 720 ending interminal loop 724 may be seen passing through and from tissue anchor722. Once assembly 708 has been desirably passed through tissue andappropriately positioned, tissue anchor 722 may be ejected from needlebody 710, e.g., using a pusher mechanism. Once free from the constraintsof needle body 710, tissue anchor 722 may be free to expand foranchoring against a tissue surface, as seen in FIG. 50B. Further detailsrelating to tissue anchors and mechanisms which may be utilized forejecting and positioning such anchors are disclosed in further detail inU.S. patent application Ser. No. 10/840,950 filed May 7, 2004, which hasbeen incorporated herein by reference above in its entirety.

As above, any of the needle assembly variations described herein is notintended to be limited to the examples described but is intended to beutilized in any number of combinations with other aspects of othervariations as practicable. Moreover, any of the variations relating tothe needle assembly variations may also be used in any number ofcombinations, as practicable, with variations of other features asdescribed above, if so desired.

Anchor Deployment

In deploying the anchors into or through the tissue, one or more anchorsmay be positioned within the launch tube for deployment. As describedabove, deployment of the anchors may be accomplished in one method bypushing the anchors via the elongate pusher element until the anchor isejected from the needle body opening. Once the anchor is free from theconstraints of the needle catheter, it may reconfigure into an expandedconfiguration for placement against the tissue surface.

To ensure that the anchor is not prematurely ejected from the needleassembly, various interlocking features or spacing elements may beemployed. As shown in the partial cross-sectional view of FIG. 51A, thecollar of proximal anchor 60 and the distal end of elongate pusher maybe interlocked with one another via a temporary interlocking feature730. Likewise, the adjacent collars of distal and proximal anchors 58,60, respectively, may be optionally interlocked with one another via atemporary interlocking feature 732 as well. Such an interlocking featuremay enable the anchor assembly to be advanced distally as well aswithdrawn proximally through sheath 654 and needle body 662 in acontrolled manner without the risk of inadvertently pushing one or moreanchors out of needle body 662.

Aside from the use of interlocking features, one or more spacingelements 734 may also be placed between adjacent anchors within sheath654 in another variation as shown in FIG. 51C. In use, as distal anchor58 is initially deployed, spacer 734 may provide additional distancebetween the adjacent anchors so that proximal anchor 60 is notinadvertently deployed along with distal anchor 58. Spacer element 734may optionally include interlocking features to temporarily interlockwith the adjacent anchors. Moreover, when proximal anchor 60 isdeployed, spacer element 734 may be ejected into the patient's body,e.g., the stomach, to simply degrade or pass naturally from the patient.Accordingly, such a spacer 734 is preferably made from any number ofbiocompatible and/or biodegradable materials.

Aside from the interlocking anchor features, the suture 76 which may berouted through anchors 58, 60 to interconnect them may also be varied inplacement with respect to the anchors. As shown in FIG. 51A, suture 76may be optionally routed such that its terminal end is deployedinitially with distal anchor 58. Alternatively, suture 76 may be routedsuch that its terminal end is deployed lastly along with proximal anchor60. Other variations for routing the suture 76 may be employed aspracticable as the foregoing examples are described merely as examplesand are not intended to be limiting in their description.

Turning back to the anchor interlocking features, FIGS. 52A and 52B showperspective views of distal anchor 58 and proximal anchor 60,respectively, having one variation for temporarily interlocking theanchors. The anchors 58, 60 are shown in their unexpanded deliveryconfiguration when positioned within the tubular delivery sheath orcatheter 654. As shown, the proximal collar of distal anchor 58 may havea circumferential-tab locking feature 744, as shown in FIG. 52A, whichis configured to inter-fit in a complementary manner withcircumferential-tab locking feature 742 on proximal anchor 60, as shownin FIG. 52B. Likewise, the proximal collar of proximal anchor 60 mayalso have a circumferential-tab locking feature 740 which is configuredto inter-fit also in a complementary manner with the locking feature 746located on the distal end of elongate pusher 666, as shown in the detailperspective view of FIG. 52C.

FIGS. 53A and 53B show another variation on the interlocking featurewhere the anchor may have a longitudinal-tab locking feature 750 or areceiving-tab locking feature 752 which is configured to inter-fit withone another in a complementary manner. FIG. 53B shows the distal end ofan elongate pusher variation having a longitudinal-tab locking feature754 for inter-fitting with the proximal collar of an adjacent anchor.

With any of the interlocking features described herein, they arepreferably configured to temporarily lock adjacent anchors and/or theanchor to the elongate pusher to one another. The positioning andorientation of the adjacent anchors and elongate pusher may be such thatthe abutting ends of each are configured to remain interlocked with oneanother when constrained by the inner surface of the sheath 654.However, when an anchor is ejected from the constraints of the sheath654 and the alignment of the anchors is skewed, the interlocking featureis preferably adapted to thus unlock itself and thereby release theejected anchor.

FIG. 54A shows another variation on a curved-tab interlocking feature760. FIG. 54B shows distal and proximal anchors 58, 60, respectively,interlocked via the curved-tab feature 760 when constrained in thesheath 654. FIG. 54C shows distal anchor 58 having been ejected andreleased from the interlocking feature 760. The interlocking feature isnot shown on the proximal end of proximal anchor 60 and other featuressuch as the elongate pusher and suture have been omitted merely for thesake of clarity.

FIGS. 55A, 55B, and 55C likewise show angled interlocking feature 770 ina detail view, between adjacent anchors, and with distal anchor 58 beingreleased from the interlocking feature 770, respectively.

FIGS. 56A, 56B, and 56C likewise show interlocking feature 780 having atab 782 and a complementary receiving groove 784 in a detail view,between adjacent anchors, and with distal anchor 58 being released fromthe interlocking feature 780, respectively.

FIGS. 57A, 57B, and 57C likewise show interlocking feature 790 having apin 792 and a complementary receiving groove 794 in a detail view,between adjacent anchors, and with distal anchor 58 being released fromthe interlocking feature 790, respectively.

FIGS. 58A, 58B, and 58C likewise show rotational interlocking feature800 having a helix or coil 802 and a complementary inter-fitting pin 804in a detail view, between adjacent anchors, and with distal anchor 58being released from the interlocking feature 800, respectively.

FIGS. 59A, 59B, and 59C likewise show electrolytic interlocking feature810 having an inter-joined electrolytically-erodable joint 812 in adetail view, between adjacent anchors, and with distal anchor 58 beingreleased from the interlocking feature 780, respectively. Theelectrolytically-erodable joint 812 may be electrically connected viawires (not shown) routed through sheath 654 to a power source locatedoutside the patient. For release of the anchor, theelectrolytically-erodable joint 812 may be eroded and leave eroded jointends 814, 816 on adjacent anchors.

FIGS. 60A, 60B, and 60C likewise show interlocking feature 820 having aballed joint 822 and a complementary receiving groove 824 in a detailview, between adjacent anchors, and with distal anchor 58 being releasedfrom the interlocking feature 820, respectively.

FIGS. 61A, 61B, and 61C likewise show balled interlocking feature 830 ina detail view, between adjacent anchors, and with distal anchor 58 beingreleased from the interlocking feature 830, respectively. Each of therespective ball joints 832, 834 are configured to inter-fit withcomplementary receiving grooves 836, 838 on adjacent anchors.

FIGS. 62A, 62B, and 62C likewise show magnetic locking feature 840having respective anchors ends 842, 844 with opposing polarities in adetail view, between adjacent anchors, and with distal anchor 58 beingreleased from the magnetic locking feature 840, respectively. Each ofthe magnets 842, 844 may be comprised of ferromagnetic materials, orthey may be electromagnetically charged.

FIG. 63 shows yet another variation which may be utilized particularlybetween an anchor and the elongate pusher. The interlocking feature 850may comprise a curved or arcuate feature, e.g., circumferential-tablocking feature 744, which may receive a cross-member 854 extendingperpendicularly from elongate member 852.

FIG. 64A shows yet another variation where elongate pusher 666 may haveone or several biased retaining arms 860, 862 extending from the distalend of pusher 666. Retaining arms 860, 862 may be biased to extendradially but may be constrained to extend radially inward whenpositioned within sheath 654. The distal ends of arms 860, 862 mayprotrude inwardly between the struts of the anchor 60 for manipulationand deployment. When pusher 666 is advanced distally, arms 860, 862 mayspring radially open to thereby release anchor 60. The proximal portionsof arms 860, 862 may be tapered such that when pusher 666 is withdrawnproximally into sheath 654, the taper on each of the arms 860, 862allows them to be drawn back into sheath 654.

FIG. 64B shows another variation in which extension member 864 mayextend distally from elongate pusher 666 to form at least one retainingarm 866 which may extend between one or more adjacent anchors 58, 60. Aspusher 666 is advanced distally, proximal anchor 60 may be released whenretaining arm 866 is fully advanced outside of sheath 654 and needlebody 662.

FIG. 64C shows yet another variation where the proximal anchor 60 may beretained to pusher 666 via a looped member 868 extending from the distalend of pusher 666. Looped member 868 may simply be looped about theproximal end of proximal anchor 60 and released by simply advancinganchor 60 out of sheath 654.

In utilizing any of the interlocking features described herein, needleassemblies may be utilized having multiple anchors for deployment intoor through tissue. FIG. 65 shows a partial cross-sectional view ofmulti-anchor variation 870 in which multiple anchors 872 may be alignedadjacently to one another in series within the sheath 654. Each of theanchors 872 may be temporarily interlocked with one another such thateach anchor 872 may be deployed sequentially in a controlled manner.

FIGS. 66A and 66B show partial cross-sectional side and bottom views ofyet another multi-anchor variation 880. In this variation, sheath 882may comprise a multi-tabbed assembly having multiple retaining tabs 884extending partially into the sheath lumen. Each of the tabs 884 may bespaced uniformly relative to one another such that a single anchor 872may be retained by a single tab 884, as shown in the FIG. 66A. As pusher666 advances distally, each of the anchors, with or without interlockingfeatures between adjacent anchors, may be advanced past a tab 884 untilthe desired number of anchors 872 has been deployed. Each tab 884 ispreferably configured to extend only partially into the lumen, asmentioned and as shown in the cross-sectional view of FIG. 66C, and ispreferably configured to flex and thereby allow for passage of an anchor872.

Although a number of illustrative variations are described above, itwill be apparent to those skilled in the art that various changes andmodifications may be made thereto without departing from the scope ofthe invention. Moreover, although specific configurations andapplications may be shown, it is intended that the various features maybe utilized in various types of procedures in various combinations aspracticable. It is intended in the appended claims to cover all suchchanges and modifications that fall within the true spirit and scope ofthe invention.

1. An apparatus for forming a tissue fold, comprising: an elongatetubular member having a proximal end, a distal end, and a lengththerebetween; an engagement member having a distal end adapted to engagetissue; a first stabilizing member and a second stabilizing memberpositioned at the tubular member distal end and adapted to stabilizetissue therebetween, wherein the second stabilizing member is maintainedin a substantially fixed position relative to the elongate tubularmember, and the first stabilizing member has a first position in whichit is biased away from the second stabilizing member, and a secondposition in which it is moved toward the second stabilizing memberrelative to the first position; and a delivery tube attached directly toand adapted to pivot about the first stabilizing member.
 2. Theapparatus of claim 1 further comprising a needle assembly slidablydisposed within the delivery tube.
 3. The apparatus of claim 2 furthercomprising an elongate hollow member connected to the needle assemblyand disposed within the delivery tube.
 4. The apparatus of claim 3further comprising an elongate pusher slidably disposed within theelongate hollow member.
 5. The apparatus of claim 2 further comprisingat least one expandable anchor slidably disposed within the needleassembly for securement against the tissue fold.
 6. The apparatus ofclaim 5 further comprising a length of suture attached to the anchor forsecurement through the tissue fold.
 7. The apparatus of claim 2 whereinthe needle assembly is adapted to be advanced from the delivery tubeperpendicular to the first or second stabilizing member.
 8. Theapparatus of claim 2 wherein the needle assembly is adapted to beadvanced from the delivery tube at an angle relative to the first orsecond stabilizing member.
 9. The apparatus of claim 2 wherein theneedle assembly comprises a cross-section which is keyed to acorresponding cross-section of the delivery tube.
 10. The apparatus ofclaim 2 wherein the cross-section of the needle assembly is selectedfrom the group consisting of circles, ellipses, rectangles, hexagons,heptagons, and octagons.
 11. The apparatus of claim 2 wherein a portionof the needle assembly is keyed to the delivery tube for maintaining anorientation of the needle assembly relative to the delivery tube. 12.The apparatus of claim 2 wherein the needle assembly comprises a needlebody having a sharpened distal end.
 13. The apparatus of claim 12wherein the needle body is hollow.
 14. The apparatus of claim 12 whereinthe needle body is curved.
 15. The apparatus of claim 13 wherein theneedle body is comprised of a shape memory alloy.
 16. The apparatus ofclaim 12 wherein the needle body is adapted to vibrate while piercinginto or through tissue.
 17. The apparatus of claim 16 further comprisesa piezoelectric transducer adapted to vibrate the needle body.
 18. Theapparatus of claim 12 wherein the needle body is adapted to be torquedvia a proximal end of the needle body.
 19. The apparatus of claim 18wherein the needle body is threaded over an outer surface.
 20. Theapparatus of claim 12 wherein the needle body defines a plurality ofdimples over an outer surface.
 21. The apparatus of claim 2 wherein theneedle assembly further comprises a lubricious layer or coating disposedover an inner and/or outer surface of the needle assembly.
 22. Theapparatus of claim 2 wherein the needle assembly further comprises alubricious layer or coating disposed over an inner surface of the needleassembly.
 23. The apparatus of claim 2 wherein the needle assemblydefines an opening along an outer surface proximally of a distal end ofthe needle assembly through which at least one expandable anchor isslidably disposed for securement against the tissue fold.
 24. Theapparatus of claim 2 wherein the needle assembly comprises a needleknife extending distally from a tapered needle body configured to dilatetissue.
 25. The apparatus of claim 2 wherein the needle assembly iscolored with a color selected from the group consisting of red, orange,yellow, green, blue, indigo, violet, silver, black, and combinationsthereof.
 26. The apparatus of claim 2 further comprising an anvilpositioned adjacent to the needle assembly and adapted to direct aneedle being advanced from the delivery tube into a curved or angledpath.
 27. The apparatus of claim 2 wherein the needle assembly comprisesa fiber optic member having a sharpened distal tip.
 28. The apparatus ofclaim 27 further comprising a processor for processing visual datareceived from the fiber optic tissue piercing member.
 29. The apparatusof claim 28 further comprising a visual display in electrical or opticalcommunication with the fiber optic member.
 30. The apparatus of claim 2wherein the needle assembly comprises a needle body having a piercingtip and a grasping arm positioned proximally of the tip, the graspingarm being adapted to project from the needle body and releasably retaina length of suture.
 31. The apparatus of claim 1 wherein the elongatetubular member comprises a flexible length.
 32. The apparatus of claim31 wherein the flexible length is adapted to be advanced through anendoscopic device.
 33. The apparatus of claim 32 wherein the endoscopicdevice comprises a shape-lockable endoscopic body.
 34. The apparatus ofclaim 32 wherein the endoscopic device is steerable.
 35. The apparatusof claim 1 wherein the elongate tubular member comprises a rigid length.36. The apparatus of claim 1 wherein the distal end of the engagementmember comprises a helically-wound member configured to pierce thetissue when rotated about its longitudinal axis.
 37. The apparatus ofclaim 36 wherein the helically-wound member defines a uniform pitch. 38.The apparatus of claim 36 wherein the helically-wound member defines anon-uniform pitch.
 39. The apparatus of claim 36 wherein thehelically-wound member comprises a second helically-wound member. 40.The apparatus of claim 36 wherein the helically-wound member defines atapered outer diameter.
 41. The apparatus of claim 36 wherein the distalend of the engagement member further comprises a needle extendingdistally through the helically-wound member.
 42. The apparatus of claim36 further comprising a pair of opposable grasping jaws positioned aboutthe helically-wound member.
 43. The apparatus of claim 36 furthercomprising at least one tissue anchor disposed within thehelically-wound member.
 44. The apparatus of claim 1 wherein theengagement member is slidably disposed through the tubular member. 45.The apparatus of claim 1 further comprising a sheath for receiving theengagement member therewithin.
 46. The apparatus of claim 45 wherein thesheath is longitudinally slidable relative to the engagement member. 47.The apparatus of claim 1 further comprising an atraumatic insertconfigured to be advanced within the engagement member.
 48. Theapparatus of claim 1 wherein the distal end of the engagement member isadapted to be electrically charged.
 49. The apparatus of claim 48further comprising a power generator in electrical communication withthe distal end of the engagement member.
 50. The apparatus of claim 1further comprising a linear bearing slidably connected to thestabilizing member.
 51. The apparatus of claim 50 wherein the linearbearing is slidably connected to the engagement member.
 52. Theapparatus of claim 51 wherein the linear bearing is adapted to slidealong the first stabilizing member when the engagement member isadvanced distally or proximally relative to the first stabilizingmember.
 53. The apparatus of claim 1 wherein the stabilizing memberdefines an opening or channel.
 54. The apparatus of claim 1 wherein thefirst and the second stabilizing members are positioned adjacent to oneanother such that a tissue receiving channel is defined therebetween.55. The apparatus of claim 1 wherein the second stabilizing member ispivotable relative to the first stabilizing member.
 56. The apparatus ofclaim 1 wherein the second stabilizing member is adapted to pivot into aclosed configuration relative to the first stabilizing member upon alinear bearing being advanced proximally over the first stabilizingmember.
 57. The apparatus of claim 1 wherein the first or secondstabilizing member is biased towards one another.
 58. The apparatus ofclaim 57 wherein the first or second stabilizing member is urged into anopen configuration relative to one another upon a linear bearing beingadvanced distally over the first stabilizing member.
 59. The apparatusof claim 1 wherein the first and second stabilizing members arearticulatable relative to one another via a linkage assembly.
 60. Theapparatus of claim 1 wherein the first or second stabilizing member isadapted to be urged away from one another.
 61. The apparatus of claim 1wherein the first stabilizing member is adapted to be urged towards thesecond stabilizing member upon the delivery tube being pivoted about thefirst stabilizing member.
 62. The apparatus of claim 1 wherein a lengthof the second stabilizing member is greater than a length of the firststabilizing member.
 63. The apparatus of claim 1 wherein the first andsecond stabilizing members each comprise an atraumatic distal end. 64.The apparatus of claim 1 wherein the second stabilizing member defines asplit opening therethrough.
 65. The apparatus of claim 64 wherein thesplit opening is defined via two articulatable arms.
 66. The apparatusof claim 1 wherein the first or second stabilizing member is adapted tobe electrically charged.
 67. The apparatus of claim 66 furthercomprising a power generator in electrical communication with the firstor second stabilizing member.
 68. The apparatus of claim 1 wherein thedelivery tube is colored with a color selected from the group consistingof red, orange, yellow, green, blue, indigo, violet, silver, black, andcombinations thereof.
 69. An apparatus for forming a tissue fold,comprising: an elongate tubular member having a proximal end, a distalend, and a flexible length therebetween; a helically-wound engagementmember adapted to engage tissue and slidably disposed through thetubular member; a first stabilizing member and a second stabilizingmember positioned at the tubular member distal end and adapted tostabilize tissue therebetween, wherein the first and second stabilizingmembers are further adapted to be angled relative to a longitudinal axisof the elongate tubular member; a delivery tube having directly a distalend that is attached to and adapted to pivot about the first stabilizingmember; and a needle assembly having a needle body slidably disposedwithin the delivery tube.
 70. The apparatus of claim 69 furthercomprising an elongate hollow member connected to the needle assemblyand disposed within the delivery tube.
 71. The apparatus of claim 70further comprising an elongate pusher slidably disposed within theelongate hollow member.
 72. The apparatus of claim 69 further comprisingat least one expandable anchor slidably disposed within the needleassembly for securement against the tissue fold.
 73. The apparatus ofclaim 72 further comprising a length of suture attached to the anchorfor securement through the tissue fold.
 74. The apparatus of claim 69wherein the needle body comprises a cross-section which is keyed to acorresponding cross-section of the delivery tube.
 75. The apparatus ofclaim 69 wherein the needle body is hollow.
 76. The apparatus of claim69 wherein the needle body is curved.
 77. The apparatus of claim 69wherein the needle body is adapted to vibrate while piercing into orthrough tissue.
 78. The apparatus of claim 77 further comprises apiezoelectric transducer adapted to vibrate the needle body.
 79. Theapparatus of claim 69 further comprising an endoscopic device throughwhich the elongate tubular member is adapted to be advanced.
 80. Theapparatus of claim 79 wherein the endoscopic device comprises ashape-lockable endoscopic body.
 81. The apparatus of claim 79 whereinthe endoscopic device is steerable.
 82. The apparatus of claim 69wherein the helically-wound member defines a uniform pitch.
 83. Theapparatus of claim 69 wherein the helically-wound member defines anon-uniform pitch.
 84. The apparatus of claim 69 wherein thehelically-wound member comprises a second helically-wound member. 85.The apparatus of claim 69 wherein the helically-wound member defines atapered outer diameter.
 86. The apparatus of claim 69 wherein the distalend of the engagement member further comprises a needle extendingdistally through the helically-wound member.
 87. The apparatus of claim69 further comprising a pair of opposable grasping jaws positioned aboutthe helically-wound member.
 88. The apparatus of claim 69 furthercomprising a sheath for receiving the engagement member therewithin. 89.The apparatus of claim 88 wherein the sheath is longitudinally slidablerelative to the engagement member.
 90. The apparatus of claim 69 furthercomprising an atraumatic insert configured to be advanced within theengagement member.
 91. The apparatus of claim 69 further comprisingcomprising a power generator in electrical communication with the distalend of the engagement member.
 92. The apparatus of claim 69 furthercomprising a linear bearing slidably connected to the stabilizingmember.
 93. The apparatus of claim 92 wherein the linear bearing isslidably connected to the engagement member.
 94. The apparatus of claim93 wherein the linear bearing is adapted to slide along the firststabilizing member when the engagement member is advanced distally orproximally relative to the first stabilizing member.
 95. The apparatusof claim 69 wherein the stabilizing member defines an opening orchannel.
 96. The apparatus of claim 69 wherein the first and the secondstabilizing members are positioned adjacent to one another such that atissue receiving channel is defined therebetween.
 97. The apparatus ofclaim 69 wherein the second stabilizing member is pivotable relative tothe first stabilizing member.
 98. The apparatus of claim 69 wherein thesecond stabilizing member is adapted to pivot into a closedconfiguration relative to the first stabilizing member upon a linearbearing being advanced proximally over the first stabilizing member. 99.The apparatus of claim 69 wherein the first or second stabilizing memberis biased towards one another.
 100. The apparatus of claim 99 whereinthe first or second stabilizing member is urged into an openconfiguration relative to one another upon a linear bearing beingadvanced distally over the first stabilizing member.
 101. The apparatusof claim 69 further comprising a power generator in electricalcommunication with the first or second stabilizing member.